MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. ROTOPRONE; BED, PATIENT ROTATION, POWERED

Model Number 209500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: 1625774, 3010048749, 3009988881, 3007420694.Currently, this product is to be handled by arjohuntleigh (b)(4)'s complaint handling establishment and any medwatch reports will be submitted under registration 9681684.A supplemental report will be provided once investigation conclusions are available.

Event Description

A customer reported that on (b)(6) 2020 a patient developed unstageable bilateral tibial pressure injuries while using a rotoprone bed.Patient was placed on the rotoprone bed on (b)(6) 2020 and removed on (b)(6) 2020, and was discharged home on (b)(6) 2020.

Manufacturer Narrative

Arjo received a mdr report from the fda # (b)(4), which was submitted by the customer through the fda¿s medical product safety network (medsun) program.Because report did not suggest that an adverse event has occurred or that an arjo device caused or contributed to the reported event, we contacted the customer to obtain detailed information.On (b)(6) 2020, arjo became aware that patient sustained unstageable bilateral tibial pressure injuries, assessed as serious injuries.The patient was placed on the rotoprone bed on (b)(6) 2020 and removed on (b)(6) 2020, and was discharged home on (b)(6) 2020.Injuries were assessed on (b)(6) 2020.According to customer¿s medical records, the patient was in prone position for 16 hours and supine for 1 hour, the patient was not rotated side to side, the patient was wearing bilateral sequential compression devices (scd), the ett was secured with cloth tape.The patient was diagnosed with acute hypoxemic respiratory failure.No additional information such as how the injuries occurred was available.As part of the investigation, we reviewed relevant arjo service records.The bed in question returned from rent on (b)(6) 2020.The same day it went through quality control process and on (b)(6) 2020 was delivered to another customer.No repairs or parts replacement were completed.The bed passed the qc process confirming it was functioning properly.From the reviewed information, arjo concluded that the reported events were potentially related to patient¿s existing medical conditions.A patient who is placed on a rotoprone bed is in a life-threatening situation physically, critically ill and typically is intubated, ventilated and sedated often with multiple co-morbidities.This patient profile is particularly vulnerable to skin ulcers/skin breakdown.There was no product failure.The rotoprone instructions for use (ifu) include warnings and precautions regarding skin care: ¿skin care ¿ fitting the head support, face pack, proning packs or other accessory packs too tightly may increase pressure points, possibly leading to 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 are not limited to, the face, ears, axilla, shoulders, sides and upper and lower extremities.Early intervention may be essential to preventing serious skin breakdown.Do not leave patient in a stationary position in the supine or prone position for more than two hours.¿ in summary, rotoprone bed was used for a patient treatment when a serious injury was noticed and therefore played a role in the event.But there was no device failure, the device met manufacturer's specification.We report this event following information that the patient sustained serious skin injury during therapy on rotoprone.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 11054533
• MDR Text Key: 223178188
• Report Number: 9681684-2020-00082
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR