MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-11-22 for 3.5V RECHARGEABLE HANDLE 71000 manufactured by Welch Allyn.
[4481598]
An initial report from a fire investigator alleges that, in the investigator's preliminary opinion, an electrical failure involving a welch allyn rechargeable handle caused a fire. The specific handle part number is unk. Based on the pictures and the presence of a 72200 battery, the handle is possibly a 71000, but the handle brand and identity cannot be confirmed at this time; nor can the actual cause of the fire; in particular the photos show multiple electrical appliances plugged into the power strip. We are filing this report in an abundance of caution until further investigation can be conducted.
Patient Sequence No: 1, Text Type: D, B5
[11833595]
Welch allyn is reporting this event in abundance of caution as it is unclear which device or component caused the problem. Note from section. The device eval is not yet complete. A f/u report will be submitted when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2013-00014 |
| MDR Report Key | 3748608 |
| Report Source | 00 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-05 |
| Date of Event | 2013-11-05 |
| Date Mfgr Received | 2013-11-05 |
| Date Added to Maude | 2014-05-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, RA DIRECTOR |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5V RECHARGEABLE HANDLE |
| Generic Name | NONE |
| Product Code | FCO |
| Date Received | 2013-11-22 |
| Model Number | 71000 |
| Catalog Number | 71000 |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |