MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for HOTBAG manufactured by Check Corp..
[37426744]
Hot bag blanket warmer started to smoke and melt on the back of the bag where the connectors are located in the bag. The power box melted. Staff were able to throw it outside before any flames or other damage. The heating element work order number was (b)(4). I notified the company and they are having their engineers review it and will send me a box to send the malfunctioning device back to them. I have 3 other hotbag blanket warmers that i inspected and feel that the connector insulation is brttle and i voluntarily pulled them from service. The company is aware of this also.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059830 |
| MDR Report Key | 5403668 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-28 |
| Date of Event | 2016-01-28 |
| Date Added to Maude | 2016-02-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HOTBAG |
| Generic Name | HOTBAG |
| Product Code | IRQ |
| Date Received | 2016-01-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHECK CORP. |
| Manufacturer Address | 1800 STEPHENSON HWY. TROY MI 48083 US 48083 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-28 |