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

Model Number 405500-CD

Device Problem Decrease in Pressure (1490)

Patient Problem Pressure Sores (2326)

Event Date 06/27/2020

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 developed pressure ulcers while being on a bariair bed.It was found that air hose was kinked.On 15 july.Additional information was provided that patient passed away due to his health condition, not related to pressure injuries.

Manufacturer Narrative

Two (2) complaints referring to the same patient but different bariair beds were reported by this customer - klinikum karlsruhe.The second complaint was submitted under mdr #3007420694-2020-00127.This report refers to the first bariair bed where a customer reported stage 2 pressure ulcer their patient sustained allegedly due to deflated mattress.The customer stated there was no alarm.The bariair system was replaced to a new bariair bed and the bed in question was evaluated in arjo service center.An arjo service technician found that one air hose connecting three seat cushions was kinked.The bariair system has seven air hoses to which different sections and cushions are connected to ensure alternating therapy.Seat cushions are connected to air hose v4 and v7, which are both placed along patients's left side of the bed.V4 air hose connects seat cushions #11, 13 and 15 and v7 connects seat cushion #12,14 and 16.When v4 air hose is kinked, pressure will not reach seat cushion 11, 13 and 15 but cushions 12, 14 and 16 remains inflated.Technician in service center performed a simulation for the reported failure - kinked v4 air hose and found that with kinked air hose, three cushions were not filled with air.Customer allegation referring to low pressure was confirmed.Three cushions were deflated due to kinked v4 air hose.It is unknown when the air hose get kinked.Another allegation referred to lack of alarm.The bariair system, which was designed and built more than 17 years ago was not designed with a low pressure alarm.Regardless of the alarm, patient skin condition shall be monitored regularly and if needed alternative therapies for high acuity patient should be considered.Early intervention may be essential to preventing serious skin breakdown.When verifying proper operation of the bed, the bariair user manual states to perform a hand check.The hand check is performed on several occasions: during air pressure adjustment, upon completion of patient placement, during regular shift check."perform a hand check beneath shoulders, hips and heels [¿]: - slide hand under cushion sleeve to rest on cushion support.- lift hand slightly to verify 1.5 to 2 in (35 to 50 mm) of air is supporting patient".Regular skin monitoring along with regular verification of air pressure in the mattress minimizes risk of serious injuries.Customer followed guidelines included in user manual acted accordingly by monitoring skin condition regularly and reacting when stage 2 pressure ulcer was noticed.The patient did not sustained a serious skin injury.This complaint is a singular occurrence.No other incidents with kinked hose were found.In summary, the bariair bed was used for patient treatment when the event occurred and for this reason played a role in the event.The bed failed to meet its performance specification due to kinked air hose.This complaint was originally reported in abundance of caution due to limited information received about an injury.Following customer clarification, there was no serious injury sustained and is unlikely that under careful medical supervision a serious injury or death occurs in the future.This failure is not considered a reportable.

• 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: 10343723
• MDR Text Key: 207183123
• Report Number: 3007420694-2020-00128
• 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