MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-01 for ROTOPRONE 209800-R manufactured by Arjohuntleigh, Inc..
[122152695]
Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc ((b)(4) from november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration (b)(4). From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and medwatch reports have been submitted under registration (b)(4). From (b)(6) 2018 medwatch reports will be submitted under registration (b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[122152696]
A patient sustained deep tissue injury to her cheek after being in prone position on rotoprone bed for 18 hours. The patient was placed on the rotoprone bed on (b)(6), patient remained in prone position for 18 hours, then the patient was turned to supine position for 4 hours to determine if patient required being placed in prone position again. Injury was noticed on (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2018-00083 |
| MDR Report Key | 7921697 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-01 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-10-01 |
| 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 | 2018-10-01 |
| Model Number | 209800-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Hospitalization | 2018-10-01 |