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

Model Number 300502

Device Problems Device Inoperable (1663); Improper Flow or Infusion (2954)

Patient Problem Injury (2348)

Event Date 11/09/2017

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 (b)(6) 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

As reported the fluidair bed went "flat" with patient laying on a hard surface.The patient had opening in the flap with white drainage which was continuing to dehisce.The nurse could not definitely attribute the dehiscence as being a result of the bed becoming flat as she stated that it may be a result of repositioning the patient or due to the patient's condition of this flap having to be redone multiple times.

Manufacturer Narrative

The investigation has been completed and conclusions are following.The customer complained about fluidair elite that stopped working and a patient was laying on a "flat" surface.The bed was swapped and the patient was moved to another fluidair elite bed.When the patient was laying on the hard surface, for about 45 minutes to 1 hour (in later conversation, the nurse stated that it could be also 30 minutes), his incision opened up and was draining white exudate.The facility could not definitely attribute the dehiscence as being a result of the bed becoming flat as she stated that "the opening is so small, and in an area where there is no way to truly say that it came from the patient being on the "flat" surface of the bed for that period of time" and it may be a result of repositioning the patient or due to the patient's condition who went through several revisions of the flap surgery.Additional information provided was that a surgeons suspected that bed not fluidizing could have contributed to wound dehiscence.When bed returned to the arjohuntleigh service center for evaluation, it was found that one of the blower did not function, which caused the fluidair surface not fluidizing.A root cause of blower failure has been identified as normal wear and tear.The complaint regarding device failure has been confirmed.When reviewing reportable complaints related to fluidair product range registered within the last 5 year, we have not found similar issue.Based on the above, it can be stated that patient's wound could have opened and continue to dehisce because of several factors: repositioning of the patient who went through several revisions of the flap surgery could contribute the issue, leaving the patient on a "flat surface" for more than 30 minutes, device failure.According to user manual 300510-ah rev.C before patient transfer to the fluidair, the device is powered on to adjust the temperature.Patient is transferred to deactivated device in order to create a near-solid patient support surface to facilitate patient transfer.When transfer is completed the fluidization is adjusted to the point until a patient is floating on support surface.Upon completion of patient placement user manual states: "verify patient is still fluidized properly and is not touching bottom of fluidization tank.Adjust fluidization as required".In case the bed is not working properly, the failure would be notice during the initial stage of patient placement.Additionally, a caregiver needs to check if bed fluidized when patient is placed on the support surface.When the event occurred the bed was used for a patient treatment and in that way played a role in the reported incident.It did fail to meet its specification as one of the component (blower) failed.We report this incident because of allegation that patient wound opened up while positioned on fluidair elite and continue to dehisce, although it cannot be definitely attributed to the bed failure.Blower failure on its own does not constitute the basis for complaint to be reportable to competent authority.

• 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: 7112630
• MDR Text Key: 94791988
• Report Number: 3007420694-2017-00226
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 300502
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization