MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-22 for ADVANTA 2 BED P1190A manufactured by Hill-rom, Inc..
[75684326]
Patient Sequence No: 1, Text Type: N, H10
[75684327]
This did not involve a patient or patient care. During preventative maintenance by the clinical engineering dept, technicians noticed a trend in a plastic bushing disintegrating. The hospital has 170 of these beds and since scrutinizing these, nine have been sequestered. Note: not all beds have been inspected- just a small sampling. One bed was repaired before this trend was noted. Technicians were not sure this would be a hazard for patients. The area where failure is occurring would be the knee/foot section of the bed. Due to the failure there is a significant amount of movement (side play) at the knee/foot section. Hill-rom representative came on site to look at the beds and since they do not have any alert/recall regarding these issues and the beds are no longer under warranty, it would be up to the hospital to repair. Technicians suggest reporting this possible/probable defect. Manufacturer response for advanta 2 hill-rom hospital bed, hill rom advanta 2 (per site reporter). Per the technician, hill rom stated there was no recall/alert regarding this issue and the beds are no longer under warranty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6581190 |
| MDR Report Key | 6581190 |
| Date Received | 2017-05-22 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-05-05 |
| Report Date | 2017-05-12 |
| Date Reported to FDA | 2017-05-12 |
| Date Reported to Mfgr | 2017-05-12 |
| Date Added to Maude | 2017-05-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANTA 2 BED |
| Generic Name | BED, AC-POWERED ADJUSTABLE HOSPITAL |
| Product Code | FNJ |
| Date Received | 2017-05-22 |
| Model Number | P1190A |
| Device Availability | * |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-22 |