MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for TRUSYSTEM 7000DV manufactured by Trumpf Medical Systems, Inc. (hill-rom, Inc.).
[133218941]
Anesthesia staff pressed the control button to move the bed into reverse trendelenberg position intraoperatively, the bed made a very loud cracking noise and suddenly dropped about an inch with the patient on it. The immediate area was inspected, no obstructions to bed movement found. The bed subsequently resumed normal operation. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8252270 |
| MDR Report Key | 8252270 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-12-17 |
| Report Date | 2019-01-07 |
| Date Reported to FDA | 2019-01-07 |
| Date Reported to Mfgr | 2019-01-16 |
| Date Added to Maude | 2019-01-16 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TRUSYSTEM |
| Generic Name | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED |
| Product Code | JAE |
| Date Received | 2019-01-16 |
| Model Number | 7000DV |
| Lot Number | 102787453 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRUMPF MEDICAL SYSTEMS, INC. (HILL-ROM, INC.) |
| Manufacturer Address | 1046 LEGRAND BLVD. CHARLESTON SC 29492 US 29492 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |