MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-25 for ROTOPRONE 209800-R manufactured by Arjohuntleigh, Inc..
[106407632]
(b)(4). An investigation was performed and conclusions are following: a customer called on 24 hour line dedicated to rotoprone users to report that a patient developed deep tissue injuries during therapy while on rotoprone bed. Customer stated that patient had injuries on nose, shin, right ear and right heel. During the call arjohuntleigh representative offered suggestions for additional skin care, customer was encouraged to assess patient skin often depending on patient's condition. No additional information have been provided. We could not confirmed if the patient was positioned and packed on the rotoprone bed properly, what was the patient medical condition at the time of the event, what was the frequency of skin assessment. The last training provided to the facility was completed on 21 march 2018. Before the asset was rented to the customer it went through quality control check on 26 march 2018 to ensure it is working in accordance to manufacturer's requirements. Post placement quality control performed on 05 april 2018 did not reveal any anomalous condition, the bed was working as intended. The rotoprone is indicated for the treatment and prevention of pulmonary complications of immobility. The rotoprone user manual (ifu) 208662-ah rev. D states that "proning itself may present inherent risk of serious injury", such as skin breakdown. Ifu indicates possible ways to minimize skin breakdown: -"assess skin at frequent intervals depending on patient condition (at least once every four hours). Give extra attention to skin at pressure points and locations where moisture or incontinence may occur or collect. Common pressure points include, but not limited to , the face, ears, axilla, shoulders, sides and upper and lower extremities. " - "early intervention may be essential to preventing serious skin breakdown", -"prolonged static positioning may increase risk of skin breakdown" moreover the rotoprone ifu informs that: "position face pack to ensure the visibility of the eyes and to avoid pressure on or around patients eyes, mouth and ears. Remove face pack at regular intervals to assess the eyes, ears and facial skin. " the rotoprone bed is equipped with an alarm, which is activated when a bed surface has been left in the prone position for more than 3 hours and 15 minutes. This function was designed to alert and remind a caregiver about patient skin assessment. 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. Review of similar reportable events, revealed that there have been reportable complaints in the past, which cover problem with patient sustaining pressure ulcer during therapy. 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. There was no product failure, the device met performance specification. We report this incident solely because of a serious injury a patient sustained.
Patient Sequence No: 1, Text Type: N, H10
[106407633]
A customer called to report that a patient developed deep tissue injuries during therapy while on rotoprone bed. Customer stated that patient had injuries on nose, shin, right ear and right heel. During the call arjohuntleigh representative offered suggestions for additional skin care, customer was encouraged to assess patient skin often depending on patient's condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00100 |
| MDR Report Key | 7457670 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-03-31 |
| Date Mfgr Received | 2018-03-31 |
| Date Added to Maude | 2018-04-25 |
| 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 | 2018-04-25 |
| Model Number | 209800-R |
| 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 | 2018-04-25 |