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

Device Problems Fire (1245); Sparking (2595)

Patient Problem No Code Available (3191)

Event Date 11/21/2017

Event Type  malfunction  

Event Description

The power cord of bed was run over by some sort of cart that sliced into the power cord causing the wires to spark and temporarily catching the wires on fire.This involved a hospital cart/machine and a hospital employee.The employee was though to be part of the respiratory department, and possibly some type of respiratory equipment like a ventilator was involved.The patient was never on the bed and it was swapped before the patient needed it.

• Brand Name: FLUIDAIR ELITE
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; yvonne mcmann; 12625 wetmore road suite 308; san antonio TX 78247
• MDR Report Key: 7094931
• MDR Text Key: 94109615
• Report Number: 7094931
• 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: 12/05/2017

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1