MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-01-29 for 3.5V RECHAREABLE HANDLE 71000-A manufactured by Welch Allyn, Inc..
[4094332]
The customer alleged that there was an electrical failure involving a welch allyn rechargable handle that caused her electrical receptacle to catch fire. The other outlet of the receptacle had a weight scale plugged into it. The actual cause of the fire cannot be determined at this time. We are filling this report in an abundance of caution until further investigation can be conducted.
Patient Sequence No: 1, Text Type: D, B5
[11614066]
Welch allyn is reporting this event in an abundance of caution as it is unclear which device or component caused the problem. The device evaluation is not yet complete. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00001 |
| MDR Report Key | 3606090 |
| Report Source | 01,05 |
| Date Received | 2014-01-29 |
| Date of Report | 2014-01-03 |
| Date of Event | 2014-01-03 |
| Date Mfgr Received | 2014-01-03 |
| Date Added to Maude | 2014-02-04 |
| 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, 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 RECHAREABLE HANDLE |
| Generic Name | NA |
| Product Code | FCO |
| Date Received | 2014-01-29 |
| Returned To Mfg | 2014-01-22 |
| Model Number | 71000-A |
| Catalog Number | 71000-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-29 |