MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-08-22 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.
[52655449]
(b)(4). Product usage when the alleged issue was detected is unknown. The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[52655450]
The customer alleges that the battery is either broken or has failed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[60953744]
(b)(4). A device history record (dhr) review was performed reviewed on the lot number of the sample received (1451v3) and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. The sample was returned for evaluation. The led would not energize upon receipt. The cartridge was connected to a known good charging unit (located on the charging end of the device). Immediately the cartridge went into a battery/circuitry fail mode with the red charging light flashing. The unit was completely disassembled for further investigation. There were no visual signs of corrosion on either end of the battery, to include the battery itself, soldered joints, and pcbs. Wires were firmly attached. After disconnecting pcb from both ends of the battery a voltage test revealed that the li-ion battery was almost fully charged at 3. 6 vdc. A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[60953745]
The customer alleges that the battery is either broken or has failed. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00243 |
| MDR Report Key | 5893415 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-08-22 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-08-05 |
| Date Mfgr Received | 2016-11-28 |
| Date Added to Maude | 2016-08-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH TRULED ADULT RECHARGEABLE BATTERY |
| Generic Name | BATTERY, RECHARGEABLE |
| Product Code | FCO |
| Date Received | 2016-08-22 |
| Returned To Mfg | 2016-09-14 |
| Catalog Number | 0055502 |
| Lot Number | 1451V3 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-22 |