MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-06 for EPICARE P680 * manufactured by Hill-rom Architectual Products.
[19075657]
Newly installed medical gas powered columns with adjustability feature failed to stay in position. Potentially dangerous when clinical equipment such as anesthesia pt monitoring equipment is below it. After several svc repair visits and continued problem, it was determined that the columns must be replaced. They were replaced with a different model: epicare column 680tl, fixed height, not adjustable. Since then rptr has not experienced any problems to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020123 |
| MDR Report Key | 299756 |
| Date Received | 2000-10-06 |
| Date of Report | 2000-10-06 |
| Date Added to Maude | 2000-10-13 |
| 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 |
| 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 | EPICARE |
| Generic Name | MEDICAL GAS COLUMN |
| Product Code | CAM |
| Date Received | 2000-10-06 |
| Returned To Mfg | 2000-09-21 |
| Model Number | P680 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 290143 |
| Manufacturer | HILL-ROM ARCHITECTUAL PRODUCTS |
| Manufacturer Address | * BATESVILLE IN 47006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-10-06 |