MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-29 for WARM TOUCH * manufactured by Mallinckrodt Inc.
[222505]
Warm touch patient warming system was attached to an upper body blanket and set at 42 degrees centigrade to 46 degrees centrigrade. When device was turned on a hot smell was noted in room. Device was disconnected, checked and replaced with no apparent injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022019 |
| MDR Report Key | 335368 |
| Date Received | 2001-05-29 |
| Date of Report | 2001-05-23 |
| Date of Event | 2001-04-06 |
| Date Added to Maude | 2001-06-04 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARM TOUCH |
| Generic Name | PATIENT WARMING SYSTEM |
| Product Code | DWI |
| Date Received | 2001-05-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 324715 |
| Manufacturer | MALLINCKRODT INC |
| Manufacturer Address | 675 MCDONNELL BLVD PO BOX 5840 ST LOUIS MO 63134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-05-29 |