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

Model Number 40060A 115V 60HZ 12A

Device Problem Fail-Safe Design Failure (1222)

Patient Problems Crushing Injury (1797); Pain (1994)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

Per rn report: patient was assisting staff to turn him in bed.The patient was using bed rail to hold on to and the side rail latch failed and the bed rail pinched the patient's r thumb.The patient's r thumb became red just before the second joint.He stated that initially he had pain, but several minutes later he reported that he was, "okay." the physician was notified and the rn received an order for a r hand x-ray.The x-ray was negative.The rn checked the bed after the patient had been moved to a new bed.He felt that there may be a design flaw in the bed rail as the rail collapsed when the rn leaned against it-bed rail latch failed.Manufacturer response for special bed-clinitron fluid air elite, ajohuntleigh fluid air elite (per site reporter).Sent to company-the bed is rented by the hospital on a day by day basis.

• Brand Name: FLUID AIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 45 barbour pond dr.; wayne NJ 07470
• MDR Report Key: 6431665
• MDR Text Key: 70791520
• Report Number: 6431665
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2017,03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 40060A 115V 60HZ 12A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR