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

Model Number 209500

Device Problem Mechanical Problem (1384)

Patient Problem Tissue Breakdown (2681)

Event Date 05/24/2020

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 ab¿s complaint handling establishment and any medwatch reports will be submitted under registration#: (b)(4).A review of service history records revealed that on may 26, 2020, an arjo service consultant visited the customer to repair the bed on site because the foot support screws were loose.A supplemental report will be provided once investigation conclusions are available.

Event Description

A customer reported that a patient suffered stage 2 interior left arm pressure injury, left lower chest flank pressure injury, right lateral rib cage pressure injury, and medical right lower legwhile using a rotoprone bed.The left lower chest flank pressure injury was assessed on may 24, 2020, the right lateral rib cage pressure injury was assessed on may 27, 2020, the medial right lower leg extremity pressure injury was assessed on may 28, 2020 and the left upper arm pressure injury was assessed on june 2, 2020.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 november 24, 2020, arjo became aware that a patient sustained not serious injuries and based on the serial number provided, we found that on 26 may 2020 the foot support (which prevents patient from sliding down toward the foot of the unit) was repaired at customer site since the screws were loose.The patient was placed on the rotoprone bed on (b)(6) 2020 and removed (b)(6) 2020, and was discharged home on july 8, 2020.The left lower chest flank pressure injury was assessed on (b)(6) 2020, the right lateral rib cage pressure injury was assessed on (b)(6) 2020, the medial right lower leg extremity pressure injury was assessed on (b)(6) 2020 and the left upper arm pressure injury was assessed on (b)(6) 2020.According to customer¿s medical records, the patient was in prone position for 18 hours and supine for 2 hours, the patient was not rotating side to side, the patient was wearing bilateral sequential compression devices (scds), the ett tube was secured with cloth tape.No additional information such as how the injuries occurred was available.When the bed returned from rent, it was quality control checked on june 5, 2020, no other failures were found, no repairs completed, the bed was functioning correctly and on (b)(6) 2020 the bed was rented again to the same customer.It was not possible to connect the failure of the foot support with the reported injuries.It is unknown how the failure occurred.With the information received, it is unknown how and why injuries occurred.We have not found reportable events where the foot support failure would lead to an injury in the past.Risk analysis file related to foot support addresses the severity of potential harm as llimited, meaning transient, self-limiting illness or injury (could cause temporary discomfort).The risk is low and acceptable.Therefore, arjo considers it unlikely that the foot support failure causes a serious injury in the future.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.¿ from the information gathered, arjo concluded that the reported event was 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.In summary, rotoprone bed was used for a patient treatment when an injury was noticed and therefore played a role in the event.It failed to meet manufacturer's specification since the foot support failed.But it unlikely that the foot support failure can lead to a serious skin injury.There was no reportable complaints in the past.We decided to report this event in an abundance of caution taking into account a report of an injury and a bed malfunction.

• 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: 11054552
• MDR Text Key: 223469861
• Report Number: 9681684-2020-00083
• 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

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR