MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-09 for MONARK ERGOMETER 881E 881 E * manufactured by Monark Excercise Ab.
[373728]
The chain slipped off of sprocket during use. Sent to biomed for repair. They were able to adjust sprocket and chain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 582461 |
| MDR Report Key | 582461 |
| Date Received | 2005-03-09 |
| Date of Report | 2005-03-09 |
| Date of Event | 2005-03-01 |
| Report Date | 2005-03-09 |
| Date Reported to FDA | 2005-03-09 |
| Date Added to Maude | 2005-03-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MONARK ERGOMETER 881E |
| Generic Name | ERGOMETER |
| Product Code | ISD |
| Date Received | 2005-03-09 |
| Model Number | 881 E |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 572291 |
| Manufacturer | MONARK EXCERCISE AB |
| Manufacturer Address | STAIR MASTER HEALTH AND FITNES 10757 EAST UTE ST. TULSA OK 74055 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-03-09 |