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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAP MEDICAL ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225; THERAPEUTIC SUPPORT SURFACE
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KAP MEDICAL ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225; THERAPEUTIC SUPPORT SURFACE Back to Search Results
Model Number NA:MA65
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  malfunction  
Manufacturer Narrative
This incident is being filed in an abundance of caution.At this time, it is unclear what, if any malfunction has occurred.Multiple attempts were made to obtain additional information regarding this incident, without success.It is unknown if the incident was caused by the outlet, the power cord or if this incident could be related to the user receiving a bath while on the mattress system.This device was over 9 years old at the time of this incident which is past the service life of 1 year.This device was supplied by kap medical.The supplier has been notified of this incident.
 
Event Description
The device was emitting flame/smoke from the plug.The device was plugged directly into a wall outlet.Damage to the plug, outlet, and wall were alleged.
 
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Brand Name
ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225
Type of Device
THERAPEUTIC SUPPORT SURFACE
Manufacturer (Section D)
KAP MEDICAL
1395 pico st
corona CA 92881
MDR Report Key15163457
MDR Text Key297228851
Report Number1531186-2022-00005
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 08/03/2022
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 NumberNA:MA65
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/06/2022
Device Age10 YR
Event Location Home
Date Report to Manufacturer08/03/2022
Initial Date Manufacturer Received 08/03/2022
Initial Date FDA Received08/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2012
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexFemale
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