MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-08 for SSCOR 2310BV manufactured by Sscor, Inc..
[85364040]
On april 20, 2017 sscor received an email from (b)(6), logistics officer of (b)(6) ems. The email indicated in the past week the department had two sscor vx-2 (model 2310bv) suction units stop working during patient care situations. After the email was received sscor followed up with (b)(6) to gather additional information. The initial indications were the device stopped working because the internal battery in the suction device had lost capacity. Sscor requested the department check all of the batteries in their devices by conducting the battery test as described in the instructions for use for the devices. Additionally, sscor sent out a total of 12 new replacement batteries for all the sscor suction units owned by the department as a precautionary measure. On (b)(6) 2017 the department reported they found that 8 of the devices had batteries with low capacity. They were able to replace these low capacity batteries with the replacement batteries sscor sent out. Sscor also discussed the battery care and maintenance procedures as described in the operations manual with the department. The department was not following the recommended battery maintenance procedures. After the discussion the department agreed to update their internal protocols and follow the battery care and maintenance procedures as described in the operations manual for the devices.
Patient Sequence No: 1, Text Type: N, H10
[85364041]
Paramedics were called to the (b)(6) due to a possible drowning. Upon arrival the paramedics found a (b)(6) female laying on the side of the indoor pool with compressions and assisted ventilations with opa and bvm being performed by the (b)(6) fire department. Acls was initiated by the paramedics, however the patient was unresponsive, the condition of the patient reported upon arrival was "dead". The chest and lung findings were absent as was a pulse. Additionally the bilateral eye findings were reported as fixed and dilated. The paramedics attempted to suction the patient using a sscor suction device and the device would not operate. There was a quick response vehicle (qrv) present and they were able to use the suction device from the qrv to treat the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022724-2017-00001 |
| MDR Report Key | 6851940 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-08 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2015-03-06 |
| Date Added to Maude | 2017-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MAIRA OJEDA |
| Manufacturer Street | 11064 RANDALL STREET |
| Manufacturer City | SUN VALLEY CA 913522621 |
| Manufacturer Country | US |
| Manufacturer Postal | 913522621 |
| Manufacturer Phone | 8185044054 |
| Manufacturer G1 | SSCOR, INC. |
| Manufacturer Street | 11064 RANDALL STREET |
| Manufacturer City | SUN VALLEY CA 913522621 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 913522621 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSCOR |
| Generic Name | VX-2 |
| Product Code | BTA |
| Date Received | 2017-09-08 |
| Model Number | 2310BV |
| Catalog Number | 2310BV |
| Lot Number | N/A |
| Operator | PARAMEDIC |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SSCOR, INC. |
| Manufacturer Address | 11064 RANDALL STREET SUN VALLEY CA 913522621 US 913522621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-09-08 |