MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-09 for ROTOPRONE 209800-R manufactured by Arjohuntleigh, Inc..
[132502776]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[132502777]
Arjo was informed about patient sustaining deep tissue injury on right cheek, right knee, left arm. Patient was in prone position in rotoprone bed on (b)(6) 2018 for 16 hours. No bed rotation ordered by a doctor due to hemodynamic instability of patient. Patient turned to supine position for care later that evening on (b)(6) for another 16 hours prone with 15 degree angle rotations to the left and right. Pressure bruising was noted, additional mepilex added, adjustments made with chest pad, shin pads not used due to some shin bruising.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00004 |
| MDR Report Key | 8230510 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-09 |
| Date of Report | 2019-02-06 |
| Date of Event | 2018-12-31 |
| Report Date | 2019-02-06 |
| Date Reported to FDA | 2019-02-06 |
| Date Reported to Mfgr | 2019-02-06 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. KINGA STOLINSKA |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJOHUNTLEIGH, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| 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 | 2019-01-09 |
| Model Number | 209800-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-09 |