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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 12/23/2013
Event Type  malfunction  
Event Description
It was reported via repair work order that the top cover of the mattress was torn and there was reported fluid ingress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported via repair work order that the top cover of the mattress was torn and there was reported fluid ingress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted because it was initially reported the device had been repaired and returned to service.However, the investigation concluded that the mattress could not be repaired as the customer has not provided a purchase order to repair their unit.Another supplemental report will be submitted if stryker conducts the repairs.
 
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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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3563921
MDR Text Key4073669
Report Number0001831750-2014-00284
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,Followup
Report Date 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2014
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
Is the Reporter a Health Professional? No
Date Manufacturer Received12/23/2013
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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