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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT MATTRESS W/O PENDANT; BED, PATIENT ROTATION, POWERED

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STRYKER MEDICAL-KALAMAZOO XPRT MATTRESS W/O PENDANT; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number 2950200000
Device Problems Moisture Damage (1405); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the mattress had fluid intrusion due to a torn bottom cover.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Mattress cover was replaced.
 
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Brand Name
XPRT MATTRESS W/O PENDANT
Type of Device
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
anthony noora
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3911929
MDR Text Key4495656
Report Number0001831750-2014-03130
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2950200000
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/09/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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