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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOAIR SUPPORT SURF. 84"END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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STRYKER MEDICAL-KALAMAZOO ISOAIR SUPPORT SURF. 84"END406; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Catalog Number 2941001100
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Pressure Sores (2326)
Event Date 04/30/2021
Event Type  Injury  
Event Description
It was reported that a patient received a pressure injury while on an isoair mattress.It was further reported that it was an unstageable pressure injury.No additional information has been provided regarding the treatment of the injury.
 
Event Description
It was reported that a patient received a pressure injury while on an isoair mattress.It was further reported that it was an unstageable coccyx pressure injury.The customer was unable to provide treatment details, and did not make the device available for testing.
 
Manufacturer Narrative
Investigation is complete.
 
Manufacturer Narrative
This supplemental record is being filed as the model number has been obtained.Investigation results still pending.
 
Event Description
It was reported that a patient received a pressure injury while on an isoair mattress.It was further reported that it was an unstageable pressure injury.No additional information has been provided regarding the treatment of the injury.
 
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Brand Name
ISOAIR SUPPORT SURF. 84"END406
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11878227
MDR Text Key253865727
Report Number0001831750-2021-00919
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2941001100
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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