MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for BATTERY CHARGER, LITHIUM ION 07-3051 manufactured by Cagentix Medical.
[24130975]
At the time of this report the device had not yet been returned. A supplemental report will be submitted if the device is returned.
Patient Sequence No: 1, Text Type: N, H10
[24130976]
Rechargeable batteries caught on fire while in charger. No one was injured. This did not occur during a procedure. This device was subjected to a recall in december of 2011 for this issue. Our records show that the customer was notified of the recall multiple times, however did not return the device as requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242464-2015-00001 |
| MDR Report Key | 5004149 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-07-15 |
| Device Manufacturer Date | 2006-10-09 |
| Date Added to Maude | 2015-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 Street | 40 RAMLAND RD. SOUTH |
| Manufacturer City | ORANGEBURG NY 10962 |
| Manufacturer Country | US |
| Manufacturer Postal | 10962 |
| Manufacturer Phone | 9524266141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BATTERY CHARGER, LITHIUM ION |
| Generic Name | LARYNGOSCOPE, ACCESSORIES |
| Product Code | CAL |
| Date Received | 2015-08-12 |
| Catalog Number | 07-3051 |
| Lot Number | 1000124T |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAGENTIX MEDICAL |
| Manufacturer Address | 40 RAMLAND ROAD SOUTH ORANGEBURG NY 10962 US 10962 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |