MAUDE Adverse Event Report: KAP MEDICAL FREEDOM 500 BED; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Smoking (1585)

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

Event Date 10/23/2019

Event Type  malfunction  

Event Description

The nurse was in giving the patient his medication and the specialty bed started to smoke.The nurse unplugged the bed but at the point smoke had filled the room.We took the patient out of the room and put a fan in it to air it out.This was the blower unit of a freedom 500 bed.Manufacturer response for surface controller unit, freedom 500 bed (per site reporter).It has been received at the freedom medical's warehouse and is to be sent to the manufacturer, kap, for their analysis.

• Brand Name: FREEDOM 500 BED
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st; corona CA 92881
• MDR Report Key: 9261110
• MDR Text Key: 164455407
• Report Number: 9261110
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 94