MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIR ELITE; BED, AIR FLUIDIZED

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

Patient Problem Pressure Sores (2326)

Event Date 01/01/2014

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 (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 any medwatch reports will be submitted under registration #(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

On (b)(6) 2018 arjo was notified about a lawsuit involving an arjo fluidair elite bed.It was stated that in 2014/2015 during in-patient stay in the va hospital, a patient developed pressure wounds on both of his calves that resulted in his right leg amputation.His left leg was saved.It was stated that during at least part of this time, he was in an arjo fluidair elite bed.There was no allegations that arjo fluidair elite bed malfunctioned.

Manufacturer Narrative

Investigation has been carried out with the following results.Arjo was notified about an event involving an arjo fluidair elite bed.It was stated that in 2014/2015 during in-patient stay in the va hospital, a patient developed pressure wounds on both of his calves that resulted in his right leg amputation.His left leg was saved.It was stated that during at least part of this time, he was in an arjo fluidair elite bed.There was no allegations that arjo fluidair elite bed malfunctioned.On 23 oct 2018 arjo received information that no other information is available due to legal actions pending.Based on that, it was decided to complete the investigation with the limited data provided.Serial number and model number of involved product was not provided, therefore no service, training records or device examination was possible.With all the limited information provided it is impossible to determine the root cause of the patient outcome.In summary, the device was used for a patient treatment and in that way played a role in the event, however there was no indication of any malfunction.We report this event in abundance of caution due to allegation of serious injury sustained by a patient.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 7959438
• MDR Text Key: 123490215
• Report Number: 3007420694-2018-00198
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/19/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention