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 2019-02-26 for ROTOPRONE manufactured by Arjohuntleigh Inc..
[137132338]
(b)(4). It was reported to arjo representative during gathering additional information to another complaint (b)(4) originated by the same (b)(6) medical center customer facility (reported under manufacturer 9681684-2019-00004), that the several patients during therapy on the rotoprone bed sustained deep tissue injuries on the knees and foreheads. No additional information have been provided related to event circumstances and how many patients sustained injuries. The rotoprone is indicated for the treatment and prevention of pulmonary complications of immobility. Rotoprone user manual (ifu) 208662-ah rev. D contains consideration for skin care. There are described ways to minimize skin breakdown as per ifu: "assess skin at frequent intervals depending on patient condition (at least once every four hours)". "do not leave patient in a stationary position in the supine or prone position for more than two hours". "early intervention may be essential to preventing serious skin breakdown", "prolonged static positioning may increase risk of skin breakdown" moreover the ifu contains information that "proning itself may present inherent risk of serious injury", such as skin breakdown. In case bed is in prone position for more than 3 hours and 15 minutes, the alarm will be activated to warn that maximum recommended prone time was exceeded. As per ifu corrective action involves "return patient to supine position to assess the skin at frequent intervals. If patient remains in prone position in excess of this time, patient may be at risk of skin breakdown or other complications. Always follow physicians orders for prone time. " the above constitute only recommendations and will not replace a clinician assessment. The therapy depends on patient 's medical condition. Please note, that the bed is used to help address potentially life-threatening conditions however, the proning itself may present risk of serious injury such as skin breakdown. The bed is not intended to prevent skin breakdown but to treat complication associated with immobility. To sum up, the rotoprone therapy system was used for patient treatment at the time of event and thus played a role in the incident. Due to fact that the system was not identified and limited information was provided to complain the root cause cannot be defined with certainty. We report this incident because of an allegation of serious injury and limited information received.
Patient Sequence No: 1, Text Type: N, H10
[137132339]
It was reported to arjo representative during gathering additional information to another complaint (b)(4) originated by the same (b)(6) medical center customer facility (reported under manufacturer 9681684-2019-00004), that the several patients during therapy on the rotoprone bed sustained deep tissue injuries on the knees and foreheads. No additional information have been provided related to event circumstances and how many patients sustained injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2019-00017 |
| MDR Report Key | 8369267 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-26 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-26 |
| 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 STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| 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 | 2019-02-26 |
| Device Availability | N |
| 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 | 2019-02-26 |