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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED Back to Search Results
Catalog Number UNK_MED
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Event Description
It was reported that the device's legs are not moving at all.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
This was originally an unknown device.The correct device was identified and evaluated.The model number and serial number were updated.The malfunction that was initially reported, was reported in error; and the actual malfunction that is now being reported is not reportable.
 
Event Description
It was reported that the device's legs are not moving at all.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
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
alex wibert
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key18950294
MDR Text Key338565659
Report Number0001831750-2024-00335
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 03/21/2024
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 Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/21/2024
Was Device Evaluated by Manufacturer? No
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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