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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GYNNIE OB-GYN STRETCHER; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO GYNNIE OB-GYN STRETCHER; STRETCHER, WHEELED Back to Search Results
Catalog Number 1061000000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2023
Event Type  malfunction  
Event Description
This report summarizes 17 malfunction events, where it was reported the devices experienced fluid leaks onto floor.There was no patient involvement.
 
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.17 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
 
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Brand Name
GYNNIE OB-GYN STRETCHER
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
brandon luckas
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key17407134
MDR Text Key319989317
Report Number0001831750-2023-00944
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327278200
UDI-Public07613327278200
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported17
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number1061000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2023
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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