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

Model Number 209800-R

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

Patient Problem Pressure Sores (2326)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc ((b)(4) from november 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration (b)(4).From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and medwatch reports have been submitted under registration (b)(4).From (b)(6) 2018 medwatch reports will be submitted under registration (b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

A patient sustained deep tissue injury to her cheek after being in prone position on rotoprone bed for 18 hours.The patient was placed on the rotoprone bed on (b)(6), patient remained in prone position for 18 hours, then the patient was turned to supine position for 4 hours to determine if patient required being placed in prone position again.Injury was noticed on (b)(6).

Manufacturer Narrative

The investigation was performed and the conclusions are following.Arjo was informed that a patient developed deep tissue injury to left cheek after being proned in the rotoprone bed.Patient was placed in prone position for more than 18 hours, then placed in supine position for care and further doctor assessment.The patient was placed on the bed on (b)(6) 2018.The injury was noted on (b)(6) 2018.The rotoprone bed was inspected after the event and found in good condition with minimal scratches and excellent function.The device was quality control checked after the event and not fault was detected, the bed met manufacturer's requirements.Please note, that the rotoprone bed is not intended for prevention of skin breakdown, the prone therapy itself may present inherent risk of skin breakdown.Product user manual (ifu) 208662-ah states that "proning itself may present inherent risk of serious injury", such as skin breakdown.Ifu indicates possible ways that can be used to help managing skin complications that can be associated with prone therapy: -"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", - "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." in practice, the treating physician assesses increased risk of skin breakdown in patients placed in the prone position in the context of the potential benefit of the therapy to the individual patient upon prescribing the therapy.Training to the customer was completed in june 2018, the skin care guidelines is included in the trainings.It was confirmed that the customer was familiar with the bed and the nurse was aware to not apply face pack to tightly.When reviewing complaints for skin injury, we (arjo) have found reportable complaints in the past.In summary, the device was used for patient treatment when the event occurred and in that way played a role in the incident, however it did not fail to meet its specification, there was not failure found, the cause of the pressure ulcer the patient sustained is related to patient medical condition and necessity of being placed in prone position.We report this incident, solely, because of a serious injury the patient sustained.

• 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: 7921697
• MDR Text Key: 122152695
• Report Number: 9681684-2018-00083
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 132