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U.S. Department of Health and Human Services

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

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ARJOHUNTLEIGH, INC. BARIAIR; BED, FLOTATION THERAPY, POWERED Back to Search Results
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.
 
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Brand Name
BARIAIR
Type of Device
BED, FLOTATION THERAPY, POWERED
Manufacturer (Section D)
ARJOHUNTLEIGH, INC.
4958 stout drive
san antonio TX 78219
MDR Report Key10343722
MDR Text Key207182890
Report Number3007420694-2020-00127
Device Sequence Number1
Product Code IOQ
Combination Product (y/n)N
Number of Events Reported1
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 Number405500-CD
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/06/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received08/21/2020
Supplement Dates FDA Received08/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
Patient Weight265
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