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 01/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted once investigation conclusions are available.Unknown serial number, therefore unknown what device was involved.

Event Description

The customer's icu education manager reported skin breakdown on patient's face (cheeks) sustained while using rotoprone bed.Following arjo clinical specialist assessment, the first injury appears to be a deep tissue injury and the second injury on the patient's cheek would be considered as unstagable due to the slough that is present which will require some type of debriding.

Manufacturer Narrative

Arjo received a complaint raised by the icu education manager from (b)(6) medical center in usa on arjo rotoprone bed.The customer¿s allegation was that the patient who was placed on the rotoprone bed since (b)(6) 2021 developed small skin breakdowns on both cheeks.The arjo clinical specialist assessed one of these injuries as a deep tissue injury and the other one as unstageable.Arjo clinical educator, after assessment of the complained issue, recommended the customer to loosen the face cradle in order to allow taking better care for the patient¿s facial area.At the time of the event no allegations were raised in relation to the device visual or functional condition.The bed was quality checked before delivery to the customer on 29-jan-2021 and quality checked after the pickup from the customer on 08-feb-2021.Both inspections did not reveal any malfunctions of this bed.No repairs were performed on this bed at that time.In relation to the complained incident, the rotoprone instructions for use (208662-ah) includes the following warnings and precautions regarding skin care and appropriate positioning of head: ¿it is very important that the patient¿s ears remain aligned with the openings in the head support.Proper positioning and alignment of the head and ears determines optimum support for the patient¿s head.Check head position often during the remainder of the patient placement procedure, especially when all other packs are positioned and tightened.¿ ¿turn head support adjustment knob to close head support around patient¿s head.Head support packs should lightly touch sides of patient¿s head without compressing the pack foam or puckering patient¿s skin.¿ in summary arjo device was used for a patient treatment when the event occurred and from that perspective it played a role in the event.The device was performing as intended.We report this event solely due to serious injury sustained by a patient while using 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: 11391583
• MDR Text Key: 233952234
• Report Number: 9681684-2021-00008
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: 209800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95