MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-09-07 for DIA-CHAIR 5800-37HM * manufactured by Discount Medical Supply.
[720230]
The patient turned on the heating component of the chair and fell asleep with the back of her neck pressed against the back of the chair. Patient reports not feeling any excessive heat during or after the treatment but did discover two small blisters on her neck the following day and reported it to the unit when she returned three days later. A physician was present to examine the patient on the date of her return and witnessed the blisters. Band aids were applied and no further treatment was required. All chairs were disconnected form the electrical outlets until the manufacturer arrives to adjust the heat setting and automatic shut off controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 925583 |
| MDR Report Key | 925583 |
| Date Received | 2007-09-07 |
| Date of Report | 2007-09-07 |
| Date of Event | 2007-08-11 |
| Report Date | 2007-09-07 |
| Date Reported to FDA | 2007-09-07 |
| Date Added to Maude | 2007-10-12 |
| 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 | DIA-CHAIR |
| Generic Name | DIALYSIS CHAIR |
| Product Code | FKS |
| Date Received | 2007-09-07 |
| Model Number | 5800-37HM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Age | 4 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 897573 |
| Manufacturer | DISCOUNT MEDICAL SUPPLY |
| Manufacturer Address | 13212 RAYMER ST. N. HOLLYWOOD CA 91605 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-07 |