MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-20 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[106011066]
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 (under registration #(b)(4)). From (b)(6) 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 any 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
[106011067]
It was reported by the customer that a patient (male) sustained "bilateral unstageable pressure injuries to zygomatic process" (as per complaint description "patient has unstageable deep tissue injury to face/cheeks"). A linc line operator who received the call reviewed proper placement as the customer was unsure if it had been followed and advice to use mepilex. It was noticed that the customer had left commercially available et (endotracheal ) tube holder - the anchorfast device at patient's cheeks without placing foam dressing under the et tube holder, the additional protection was placed on forehead and chin. Treatment provided: vaseline gauze was applied as directed by (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00098 |
| MDR Report Key | 7446143 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-20 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2018-04-20 |
| 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 | 2018-04-20 |
| Model Number | 209500 |
| Operator | NURSE |
| 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 | 2018-04-20 |