MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. FLUIDAIR ELITE; BED, AIR FLUIDIZED

Model Number 300502

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.The information was passed to the manufacturer.The conclusions will be provided within the manufacturer's follow-up report 3007420694-2022-00095 once the investigation is completed.

Event Description

Following the information provided the patient was placed on the fluidair elite bed when the silicone beads that fill the bed, spreaded out into the air, landing on the patient's body and on the floor.The staff observed a small puncture in the bed cover sheet of an unknown origin.The outcome to the patient is unknown at this time.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• MDR Report Key: 14753959
• MDR Text Key: 294588767
• Report Number: 1419652-2022-00029
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/21/2022

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: Health Professional
• Device Model Number: 300502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2022
• Distributor Facility Aware Date: 05/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other