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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EZ-PRO R4 AMBUL COT OBS(5/08); STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO EZ-PRO R4 AMBUL COT OBS(5/08); STRETCHER, WHEELED Back to Search Results
Catalog Number 6092000000
Device Problems Component Falling (1105); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/31/2013
Event Type  malfunction  
Event Description
It was reported by repair work order that the customer alleged the cot dropped.It was identified by the technician that the center weldment flange bearings and the tube spindles were missing.The customer decided not to repair this unit.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The customer decided not to repair the unit.
 
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Brand Name
EZ-PRO R4 AMBUL COT OBS(5/08)
Type of Device
STRETCHER, WHEELED
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 Key3591826
MDR Text Key4037375
Report Number0001831750-2014-00766
Device Sequence Number1
Product Code FPO
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 12/31/2013
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
Device Operator Other
Device Catalogue Number6092000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 12/31/2013
Initial Date FDA Received01/24/2014
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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