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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2972000000
Medical Device Problem Code Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was not evaluated; the issue was reported by the customer, but they did not require an evaluation as no product malfunction/defect is alleged.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 it was difficult to perform x-rays with the mattress.There was patient involvement, however there were no consequences or impacts to the patient.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - D
Common Device Name
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8279085
Report Number0001831750-2019-00025
Device Sequence Number1500346
Product Code IKZ
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) 01/25/2019
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 Catalogue Number2972000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/01/2019
Initial Report FDA Received Date01/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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