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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 02/14/2023
Event Type  malfunction  
Event Description
It was reported that the device failed to retract its legs while loading, followed by total failure of the legs to move at all.The patient was not affected, and no adverse consequence or clinically relevant delay in treatment was reported.Attempts are being made to gather more information from the user facility.
 
Manufacturer Narrative
The device has been identified and evaluated.The catalog and serial numbers have been added.Section h codes have been updated.
 
Event Description
It was reported that the device failed to retract its legs while loading, followed by total failure of the legs to move at all.The patient was not 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 Key16504543
MDR Text Key310902025
Report Number0001831750-2023-00306
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,Followup
Report Date 04/24/2023
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/14/2023
Initial Date FDA Received03/08/2023
Supplement Dates Manufacturer Received02/14/2023
Supplement Dates FDA Received04/24/2023
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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