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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO 2 AMBULANCE COT; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO POWER PRO 2 AMBULANCE COT; STRETCHER, WHEELED Back to Search Results
Catalog Number 650700000000
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2023
Event Type  malfunction  
Event Description
It was reported that the retractable handle on the device is not locking in position.It was also reported that when users grab the handle to take out the cot, it detaches and the user falls backwards.However, no serious injury or adverse consequences were reported.Attempts are being made to gather additional details from the user facility.
 
Event Description
It was reported that the retractable handle on the device is not locking in position.It was also reported that when users grab the handle to take out the cot, it detaches and the user falls backwards.However, no serious injury or adverse consequences were reported.
 
Manufacturer Narrative
A stryker senior specialist, post-market surveillance, reached out to a stryker sales rep about this issue.They confirmed that the unit was repaired for the customer by a third party service and that additional details of the repair are not available.They stated that nothing else is needed from stryker at this time.Based on the investigation, the stryker senior qae determined that the issue of false engagement of wagon handle in the horizontal position was likely due to the foot section: retractable wagon handle latch needing alignment/adjustment.
 
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Brand Name
POWER PRO 2 AMBULANCE COT
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
alex wibert
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key17932897
MDR Text Key325634112
Report Number0001831750-2023-01027
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327504460
UDI-Public07613327504460
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/04/2024
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 Number650700000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/02/2023
Initial Date FDA Received10/13/2023
Supplement Dates Manufacturer Received10/02/2023
Supplement Dates FDA Received01/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/18/2023
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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