MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for JR 90032 manufactured by Sscor, Inc..
[123415898]
In one day surgery, staff preparing for a case; battery did not work, failed before the two year replacement window. Manufacturer response for aspirator, (brand not provided) (per site reporter). Per bio med manufacturer instructed to discard and replace. Battery was recycled and a new one was ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7955762 |
| MDR Report Key | 7955762 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-07-11 |
| 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 |
| Generic Name | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) |
| Product Code | BTA |
| Date Received | 2018-10-11 |
| Model Number | JR 90032 |
| 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 |