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 2019-05-08 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[144405306]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[144405307]
Arjo was notified on (b)(6) 2019 that a female patient sustained pressure injuries while on the rotoprone system. It was reported by the customer that the patient had skin assessed on (b)(6) 2019 (it could not been done earlier due to long prone times) and found a stage 1 pressure injury on the right heel, slight and minor deep tissue injury under right eye. The customer inspected the bed and found that on the right foot board there was less padding that on the left one. Also less padding was noticed on the interior right side "rail". Deep tissue injury was further described as, "overall looks pretty good," and, "it should resolve in a day or two".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00045 |
| MDR Report Key | 8590589 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-08 |
| Date of Report | 2019-07-24 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-05-28 |
| Date Added to Maude | 2019-05-08 |
| 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 | 2019-05-08 |
| Model Number | 209500 |
| 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 | 2019-05-08 |