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 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided upon investigation conclusion.

Event Description

The arjo representative was informed about the event involving the rotoprone bed.The wound care nurse (from the facility) informed that the patient sustained deep tissue injury on the face due to worn face pack padding.After the event, the face covers, foams, and headpiece pads were returned to the arjo service center for inspection.During the parts evaluation, it was confirmed that no malfunction was found.The customer allegation that the face pack was worn could not be confirmed as the part has no sign of defect.

Manufacturer Narrative

The follow up report is submited for correctiom.The importer reprot was send by mistake.As the rotoprone bed was manufactured in the usa.The importer reported is not required.

Event Description

The follow up report is submited for correctiom.The importer reprot was send by mistake.As the rotoprone bed was manufactured in the usa.The importer reported is not required.

Manufacturer Narrative

Correction to section e and d.5 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 9681684.An arjo sale representative received a call from a wound care nurse who reported that their patient sustained bilateral deep tissue injury to cheeks allegedly from a worn rotoprone face pack padding.The face covers, foams, and headpiece pads were returned to an arjo service center for inspection.No defects, incl.Worn covers or foams were found.Then, the bed was repaired because the head rest shaft was missing for unknown reason and needed to be replaced.This part ensures that the head support is stable during bed rotation.It is unknown when the part got lost but it is unlikely that this missing component could influence on patient¿s cheeks causing deep tissue injury.There was no reportable event in the past involving the head rest shaft.There are several other factors which could lead to skin injury.Product instruction for use (ifu) 208662-ah rev e lists some of them, e.G.Face packs fitting too tightly or prolonged static positioning.Ifu includes safety information as well as guidelines and steps that can be considered when managing potential face skin complications that can be associated with prone therapy: ¿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, the bed was used for the 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.

• 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: 10512705
• MDR Text Key: 206303650
• Report Number: 9681684-2020-00056
• 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,Followup
• Report Date: 09/22/2020

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: 209500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/10/2020; 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention