MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for SENTINEL 2315 AE-6905 manufactured by Sscor, Inc..
[123402600]
Setting up for a case, testing battery and it failed (before 2 year replacement window), manufacturer response: for aspirator, (brand not provided) (per site reporter)manufacturer notified, instructed to recycle the battery and replacement ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7955834 |
| MDR Report Key | 7955834 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-05-07 |
| Report Date | 2018-09-27 |
| Date Reported to FDA | 2018-09-27 |
| Date Reported to Mfgr | 2018-10-11 |
| Date Added to Maude | 2018-10-11 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SENTINEL |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2018-10-11 |
| Model Number | 2315 |
| Catalog Number | AE-6905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SSCOR, INC. |
| Manufacturer Address | 11064 RANDALL STREET SUN VALLEY CA 91352 US 91352 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |