MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-30 for ROTOPRONE 209800 manufactured by Arjohuntleigh, Inc..
[103939865]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[103939866]
Arjohuntleigh was informed that a patient, who was placed in rotoprone bed on (b)(6) 2018 developed multiple pressure ulcers to right and left thigh, left knee, shin, foot (assessed as stage 1 and 2, deep tissue injury). Because patient tolerated less then 2 minutes in supine position, a closer skin examination on (b)(6) was not possible. Physician ordered patient to be left in prone position with no rotations. Patient was in this position for more than 30 hours. Patient skin was assessed on (b)(6). Treatment provided: mepilex border. There was no device failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00078 |
| MDR Report Key | 7384889 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-30 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-04-14 |
| Date Added to Maude | 2018-03-30 |
| 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 | 2018-03-30 |
| Model Number | 209800 |
| 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 | 2018-03-30 |