MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for CARE-E-VAC 3 manufactured by Ohio Medical, Llc.
[56564507]
Patient Sequence No: 1, Text Type: N, H10
[56564508]
A patient collapsed during therapy. As the patient was being resuscitated, there were concerns that the portable suction unit was not working properly. The white tops on the suction canister were cracking. The wrong lids were being used on the canisters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6002600 |
| MDR Report Key | 6002600 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-22 |
| Date of Event | 2015-11-17 |
| Report Date | 2016-09-22 |
| Date Reported to FDA | 2016-09-22 |
| Date Reported to Mfgr | 2016-09-22 |
| Date Added to Maude | 2016-10-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARE-E-VAC 3 |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2016-10-06 |
| Model Number | CARE-E-VAC 3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL, LLC |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-06 |