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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 2972
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; there was a broken/damaged component.The device was repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported there was accessible electric current.  there was no patient involvement.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - D
Common Device Name
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10001167
Report Number0001831750-2020-00402
Device Sequence Number2184724
Product Code FNM
UDI-Device Identifier07613327278453
UDI-Public07613327278453
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/27/2020
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
Operator of Device No Information
Device Model Number2972
Device Catalogue Number2972000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/01/2020
Initial Report FDA Received Date04/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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