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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TRANSPORT SERIES OBS10/25/04; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO TRANSPORT SERIES OBS10/25/04; STRETCHER, WHEELED Back to Search Results
Catalog Number 0721000000
Device Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.(b)(4) 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.
 
Event Description
This report summarizes (b)(4) malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage.There was no patient involvement.
 
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Brand Name
TRANSPORT SERIES OBS10/25/04
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
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19154314
MDR Text Key341246189
Report Number0001831750-2024-00370
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2024
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 Number0721000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/22/2024
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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