MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. BARIAIR; BED, FLOTATION THERAPY, POWERED

Model Number 405500-CD

Device Problems Decrease in Pressure (1490); No Apparent Adverse Event (3189)

Patient Problems No Consequences Or Impact To Patient (2199); Pressure Sores (2326)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon investigation conclusion.

Event Description

Arjo was notified by a customer representative that allegedly a patient's pressure ulcers got worse while being on a bariair bed.No specific information about patient's state of health or stage or pressure ulcer was provided.On 15 july.Additional information was provided that patient passed away due to his health condition, not related to pressure injuries.No failure was detected within the system.

Manufacturer Narrative

Originally provided information on (b)(6) 2020 by an arjo training and acute application specialist was that the patient's pressure ulcers got worse while being on a bariair bed.The bariair bed in question was delivered to the hospital as a replacement for the other bariair bed where kinked hose was found and where patient developed stage 2 pressure ulcer.Report for the first complaint was submitted under mdr #3007420694-2020-00128.On (b)(6) a following communication was received that the patient passed away due to his health condition, not related to the pressure ulcer.Later, on (b)(6) arjo received a fax, where the customer provided clarification to the complaint stating that they noticed that the newly delivered bariair bed had too little air in the cushions and arjo technician, who visited them could not adjust the pressure, either.On (b)(6) customer provided another feedback stating the patient¿s skin condition did not improve on this new bariair bed allegedly due to the bed not being properly inflated.The bariair bed in question (the bed belongs to german rental fleet) was tested in the service center and no fault was found.Bariair cushions were tested for back pressure and they passed the requirements.Customer allegation could not be confirmed.The bariair system user manual states to monitor patient skin condition regularly and if needed alternative therapies for high acuity patient should be considered: "skin care - monitor skin conditions regularly, particularly at bony prominences and in areas where incontinence and drainage occur or collect, and consider adjunct or alternative therapies for high acuity patients.Early intervention may be essential to preventing serious skin breakdown." the bariair system did not meet customer¿s expectations, therefore citadel plus was offered instead.Customer decided to not renting the bariair system any more.In summary, the bariair bed was used for patient treatment when the alleged lower pressure was noticed and for this reason played a role in the event.The bed did not fail to meet its performance specification, no failure was found during bed¿s inspection.Customer allegation could not be confirmed.The patient did not sustained an injury, skin condition did not worsen while being on this bed.There was no connection between patient¿s death and the bariair system.This complaint was reported in abundance of caution because original information suggested an injury.Following customer clarification, there was no injury sustained and is unlikely a serious injury or death occurs in the future.This complaint is not considered meeting a reportable criteria.

• Brand Name: BARIAIR
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 10343722
• MDR Text Key: 207182890
• Report Number: 3007420694-2020-00127
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 08/31/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 405500-CD
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 265