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

Model Number 405500-R

Device Problems Material Puncture/Hole (1504); Smoking (1585); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(6) 2019 arjo was notified about bariair therapy system failure.It was reported that smoke and smell was coming out from the mattress under the patient's head.The patient was immediately transferred to another bed and the fire extinguishers were used.Deformed battery was identified as a source of the smoke.It was taken outdoors and the hospital room was ventilated.No injury was sustained.

Manufacturer Narrative

Customer reported smoke in the room and acid smell coming from the bariair therapy system.The patient was transferred immediately to another bed.A foam extinguisher was used on the bed to put out a smell.There was no injury nor any other health consequences reported.Upon device inspection it was found that one of the two batteries became damaged.There was a hole in the battery cover and the battery itself looked as if the pressure inside had increased deforming the cover.When a lead acid battery is overcharged, the electrolyte solution can overheat, causing hydrogen and oxygen gasses to form, increasing pressure inside the battery.The bariair therapy system has two 12-volt, 24-ampere-hour, sealed, batteries, which are recharged by inverter during operation.The last battery replacement was in july 2017.Before the bed was rented to the customer it went through quality control check on 09th december 2019 and electrical safety test has been performed on 23rd july 2019.No discrepancies were found.The bed was delivered to the customer in full working condition on 9 dec 2019.When the bed returned to the arjo service center it was inspected by arjo repair technician.The inverter could not be checked because it became damaged during foam extinguishing, but the wires looked good, no signs that would indicate the cause of the battery failure.The bed was plugged into the power source, without battery, and it worked correctly.When reviewing complaints about bariair for the last 5 years, no other complaints were found.The reported event is a singular occurrence.In summary, the device was used for patient treatment when it failed, and was directly involved in the event.It failed to meet its specification because of battery outgassing, however it is unknown what caused the battery failure.There was no injury in regards to this failure and the probability of harm is remote.This complaint was deemed reportable with caution approach.

Manufacturer Narrative

Following sections have been corrected: d point 2.A.And 2.B., and serial number in point 4.We would like to inform also that damaged battery was sent for inspection and currently we are waiting for results.

• 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: 9568402
• MDR Text Key: 198518045
• Report Number: 3007420694-2020-00002
• 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,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 405500-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/16/2019; 12/16/2019
• Supplement Dates FDA Received: 02/07/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 168