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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 5TH WHL STRTCHR, PRIME X, PWRD; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO 5TH WHL STRTCHR, PRIME X, PWRD; STRETCHER, WHEELED Back to Search Results
Catalog Number 1105000000XE
Medical Device Problem Code Device Slipped (1584)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
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; there were worn or missing 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 6 malfunction event, where it was reported the mattress slipped off the litter.There was patient involvement, however there were no consequences or impacts to the patient.
 
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Brand Name
5TH WHL STRTCHR, PRIME X, PWRD
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8555198
Report Number0001831750-2019-00401
Device Sequence Number400352
Product Code FPO
UDI-Device Identifier07613327278224
UDI-Public07613327278224
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized6
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/26/2019
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 Number1105000000XE
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/01/2019
Initial Report FDA Received Date04/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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