MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-31 for THE VEST 205 * manufactured by Hill-rom Services, Inc..
[3497034]
As our central equipment technician was transporting a portable therapy vest, one of the trolley wheels got caught on a carpet threshold causing the device to tip over. As the technician was trying to "catch" the device from completely tipping over the device's leg struck her lower leg and caused bruising and contusions. Initial inspection of the therapy vest and cart showed that the cart column was extended to the upmost position (48") causing a high center of gravity increasing the tip factor. ======================manufacturer response for pneumatic therapy vest, portable, the vest (per site reporter). ======================manufacturer to follow up. What was the original intended procedure? Transporting equipment. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3148643 |
| MDR Report Key | 3148643 |
| Date Received | 2013-05-31 |
| Date of Report | 2013-05-31 |
| Date of Event | 2013-05-28 |
| Report Date | 2013-05-31 |
| Date Reported to FDA | 2013-05-31 |
| Date Reported to Mfgr | 2013-06-06 |
| Date Added to Maude | 2013-06-06 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE VEST |
| Generic Name | PERCUSSOR, POWERED-ELECTRIC |
| Product Code | BYI |
| Date Received | 2013-05-31 |
| Model Number | 205 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM SERVICES, INC. |
| Manufacturer Address | 1069 STATE RT 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-31 |