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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 Code Arcing (2583)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/25/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the when the batteries are connected to the cot there have been instances of arcing.This causes sparking and has resulted in erosion of the battery terminals in the cot, indicating dc discharge >24v.There was no report of patient involvement or adverse consequences.
 
Additional Manufacturer Narrative
The device evaluation has been completed and section h codes have been updated.
 
Event or Problem Description
It was reported that the when the batteries are connected to the cot there have been instances of arcing.This causes sparking and has resulted in erosion of the battery terminals in the cot, indicating dc discharge >24v.There was no report of patient involvement or adverse consequences.
 
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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 Key11229786
Report Number0001831750-2021-00142
Device Sequence Number11603059
Product Code FPO
UDI-Device Identifier07613327261660
UDI-Public07613327261660
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/21/2021
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
Initial Date Received by Manufacturer 01/25/2021
Supplement Date Received by Manufacturer01/25/2021
Initial Report FDA Received Date01/26/2021
Supplement Report FDA Received Date04/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
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