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

Model Number 209800

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

Patient Problem Pressure Sores (2326)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).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).The rotoprone bed was delivered to this facility on (b)(6) 2020 and returned from rent on (b)(6) 2020.The same day it passed quality control inspection and was rented again to the same facility.There was no repairs completed on the bed, no service records found.The rotoprone therapy system is a patient care system for the prevention and treatment of complications associated with immobility.Although the use of the device is designed to help caregivers address potentially life-threatening conditions, proning itself may present inherent risk of injury.Caregivers should always address and discuss safety information, risks and precautions with the patient (or the patient¿s legal guardians) and the patient¿s family.Product instruction for use (ifu) #(b)(4) includes guidelines and steps that can be considered when managing potential skin complications that can be associated with prone therapy.Safety information included in ifu states to not leave patient in a stationary position in the supine or prone position for more than two hours.There was no product failure, patient medical condition required prone positioning for more than 2 hours to address his medical condition.A customer's staff received an additional education on skin precautions on 1 oct 2020.The device was used for patient treatment when the event occurred, therefore played a role in the event, but there was no failure that could contribute to the reported injury.We report this event because of serious injury patient sustained.

Event Description

A critical care clinical nurse specialist from (b)(6) hospital reported to arjo that their patient developed multiple skin injuries (necrotic left nipple - stage 4, a sacral wound - stage unknown) over the course of his stay on a rotoprone bed.According to arjo account manager, the patient's skin was protected prior to his placement on the bed.The patient was in prone position for 16 - 18 hours and injury was noted when he could be placed in supine position.

• Brand Name: ROTOPRONE
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 688282467
• MDR Report Key: 10733065
• MDR Text Key: 212995415
• Report Number: 9681684-2020-00068
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2020

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: 209800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention