MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-11 for * 791-12 manufactured by Nemschoff.
[2257739]
There became an issue with the heaters on the chairs not working. There was a pad being used on the back of the chair and when that was removed there appeared to be a burn mark on the back of the chair. At that time the department was instructed not to use any heaters on the chairs until the company was notified and the chairs repaired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2272038 |
| MDR Report Key | 2272038 |
| Date Received | 2011-09-11 |
| Date of Report | 2011-02-02 |
| Date of Event | 2011-02-02 |
| Report Date | 2011-02-02 |
| Date Reported to FDA | 2011-09-11 |
| Date Added to Maude | 2011-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | RENAL DIALYSIS CHAIR |
| Product Code | FKS |
| Date Received | 2011-09-11 |
| Returned To Mfg | 2010-02-01 |
| Model Number | 791-12 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEMSCHOFF |
| Manufacturer Address | 909 NORTH 8TH STREET SHEBOYGAN WI 53081 US 53081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-11 |