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

Model Number 405500-CD-R

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results of the analysis will be provided to the follow-up report.

Event Description

It was reported by the customer that the cable fire allegedly occurred.The patient smelled odours and reported it to the nurses.The nurses notified the electrician from the facility and the bed was disconnected from the power source and forwarded to the corridor.No injury was reported.The device evaluation performed by the arjo technician did not reveal any burning marks or fire traces on the bed, also no smell was confirmed.

Manufacturer Narrative

It was reported by the customer that the cable fire allegedly occurred.The patient smelled odours and reported it to the nurses.The nurses notified the electrician from the facility and the bed was disconnected from the power source and forwarded to the corridor.No injury was reported.The device evaluation performed by the arjo technician did not reveal any burning marks or fire traces on the bed, also no smell was confirmed.Based on the collected information and results of the bed inspection, the customer¿s allegation was no confirmed.The source of the alleged fire and odour seems to be not related to the arjo device.Arjo device was used by a patient when the alleged event occurred and from that perspective it played a role in the event.Allegedly, the cable fire occurred but it was not confirmed during the bed frame evaluation.The complaint decided to be reportable due to the customer allegation concerning fire of the cable.No injury was claimed.

• Brand Name: BARIAIR
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 17508003
• MDR Text Key: 320854211
• Report Number: 3007420694-2023-00190
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405500-CD-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male