MAUDE Adverse Event Report: KAP MEDICAL MICROAIR ALTERNATING PRESSURE 9153649538; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number NA:MA65B42

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

The power cord was returned and an evaluation is being done but not yet completed.A replacement cord was sent out.Should additional information become available, a supplemental record will be filed.

Event Description

The caller stated the power cord caught fire two days ago.She stated she is the caregiver and she had just stepped away and heard a sound that was like a firecracker, she saw sparks like a sparkler and black smoke.The cord for the mattress was plugged into the wall and that cord along with the other power cord for the electric bed were taped out of the way.The power cord to the electric bed was not damaged but there is a small hole in the cord to the mattress.She stated they spliced the active wires together in order to continue to have the bed work.

• Brand Name: MICROAIR ALTERNATING PRESSURE 9153649538
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st; corona CA 92881
• Manufacturer (Section G): KAP MEDICAL; 1395 pico st; corona CA 92881
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 6591441
• MDR Text Key: 75974907
• Report Number: 1531186-2017-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 04/26/2017

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: Lay User/Patient
• Device Model Number: NA:MA65B42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 05/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 136