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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED Back to Search Results
Model Number 6550
Medical Device Problem Codes Protective Measures Problem (3015); Device Fell (4014)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; the device had a broken/damaged component and incompatible restraints.The device was repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event or Problem Description
This report summarizes 1 malfunction event, where it was reported the cot dropped and had inadequate patient restraints.There was no patient involvement.
 
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Brand Name
POWER-PRO TL COT
Common Device Name
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10325660
Report Number0001831750-2020-00864
Device Sequence Number2246468
Product Code FPO
UDI-Device Identifier07613327261660
UDI-Public07613327261660
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/27/2020
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 Model Number6550
Device Catalogue Number6550000000
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/01/2020
Initial Report FDA Received Date07/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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