MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for ROTOPRONE manufactured by Arjohuntleigh Polska Sp. Zo.o..
[146048497]
Recently placed pt in rotoprone bed at 0435. Began proning pt at 0455. Checked red manual rotation latch and bed brakes before rotation began. Pt was tolerating bed well on rotation. At approx. 0615, rn was standing at the head of the bed when suddenly the red manual rotation latch flung open and patient's bed quickly began to rotate manually on its own. Rn quickly grabbed the bed along with team lead and fellow rn who happened to be standing in the doorway of the room. Bed was manually brought back to zero degrees and lock pin was pulled. Rn zip-tied the red manual rotation latch shut, and notified manufacturer rep of bed malfunction and to order a new bed immediately. Nurse manager notified. Rn spoke with manufacturer rep, customer service reps and ordered a new rotoprone bed to be brought to the patient's room immediately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8639729 |
| MDR Report Key | 8639729 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-01-04 |
| Report Date | 2019-05-22 |
| Date Reported to FDA | 2019-05-22 |
| Date Reported to Mfgr | 2019-05-24 |
| Date Added to Maude | 2019-05-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ROTOPRONE |
| Generic Name | BED, PATIENT ROTATION, POWERED |
| Product Code | IKZ |
| Date Received | 2019-05-24 |
| Returned To Mfg | 2019-01-04 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | 12625 WETMORE ROAD SUITE 308 SAN ANTONIO TX 78247 US 78247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |