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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO FLOOR MOUNT FASTENER SNGL PLT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO FLOOR MOUNT FASTENER SNGL PLT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6370000000
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 07/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; the devices had loose components.The devices were repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 2 malfunction events, where it was reported the cot fastener had insufficient retention force.There was no patient involvement.
 
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Brand Name
FLOOR MOUNT FASTENER SNGL PLT
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8009636
Report Number0001831750-2018-01158
Device Sequence Number16214554
Product Code FPO
UDI-Device Identifier07613327261622
UDI-Public07613327261622
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized2
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2018
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
Operator of Device No Information
Device Catalogue Number6370000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2018
Initial Report FDA Received Date10/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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