MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-26 for ROTOPRONE 209500 manufactured by Arjohuntleigh, Inc..
[100893400]
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 #1625774). From november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #3009988881. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration #307420694. The investigation was performed and the conclusions are following: a customer nursing staff called to report that a patient developed three pressure ulcer during therapy while on rotoprone bed. The wound care nurse stated that the patient developed a pressure ulcer stage ii on left heel, deep tissue injury on the right foot and an unstageable pressure ulcer on the left face (cheek area). The nurse was asking for suggestion and guidance as to the skin care. An arjohuntleigh regional critical care clinical educator informed that the patient placement guidelines and the skin care guidelines forms have been sent to the customer and additional training is to be scheduled upon the customers convenience. No information regarding patient care or placement onto the rotoprone bed was provided by the customer. The rotoprone bed was pre-placement inspected in accordance to quality control check and passed the manufacturer's requirements. After it was returned from rental, it was tested per quality control procedures post placement: the bed passed qc checks, functioned as designed and met specifications. No anomalous conditions were found on the bed. User manual (ifu) 208662-ah rev. D states that "proning itself may present inherent risk of serious injury", such as skin breakdown. There are, however, ways to minimize skin breakdown. Ifu states: do not fit the head support, face pack, proning packs and other accessory pack too tightly as this may increase pressure point, possibly leading to skin breakdown, skin shall be assess at frequent intervals depending on patient condition (at least every four hours), common pressure points include face, ears, axilla, shoulders, sides and upper and lower extremities and those point shall be given extra attention to, early intervention may be essential to preventing serious skin breakdown, do not leave patient in a stationary position in the supine or prone for more than two hours, "prolonged static positioning may increase risk of skin breakdown", "remove excess moisture and keep skin dry and clean at all time", "remove face pack at all times patient is in supine position", "remove face pack at regular intervals to assess the eyes and surrounding skin", "when supine, elevate heels off of therapy surface" because friction on the feet can contribute to skin breakdown. Place prophylactic shear/pressure pads on areas such as: cheeks, forehead, knees, etc.. Do not place packs directly over toes, knees feet or top of foot. There was no product failure. It is unknown which factor could contribute to the patient outcome. It is worth remembering however that proning itself may present a risk of serious injury. Thus, caregivers should make sure to discuss safety information, risk and precautions with the patient (or the patient's legal guardians) and the patient's family. In summary, the device was used for patient treatment when the event occurred and in that way played a role in the incident, however it did not fail to meet its specification, there was no failure found. The root cause of this event cannot be determined. We report this incident solely because of serious injuries sustained.
Patient Sequence No: 1, Text Type: N, H10
[100893402]
A customer nursing staff called to report that a patient (b)(6) developed three pressure ulcer during therapy while on rotoprone bed. The wound care nurse stated that the patient developed a pressure ulcer stage ii on left heel, deep tissue injury on right foot and an unstageable pressure ulcer on the left face (cheek area).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00048 |
| MDR Report Key | 7295650 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-01-31 |
| Date Added to Maude | 2018-02-26 |
| 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. 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 | 2018-02-26 |
| Model Number | 209500 |
| Operator | NURSE |
| Device Availability | Y |
| 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. Other | 2018-02-26 |