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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT; STRETCHER, WHEELED Back to Search Results
Catalog Number 6506000000
Device Problem Misassembled During Installation (4049)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 05/20/2019
Event Type  Injury  
Event Description
It was alleged that 2 device users got injured due to an incorrectly installed hook that attaches the safety bar.It was reported that one person received a pinched finger and the other person received a broken finger.
 
Manufacturer Narrative
It was initially reported that two users were injured while using the device in this report.Upon further discussion with the customer, it was clarified that the two users were injured in separate events.This mdr has been filed for the event of the user with the pinched finger.The event of the user whose finger was broken is captured in mdr with mfr# 0001831750-2019-00599.
 
Event Description
It was alleged that 2 device users got injured due to an incorrectly installed hook that attaches the safety bar.It was reported that one person received a pinched finger and the other person received a broken finger.
 
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Brand Name
POWER PRO 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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8705289
MDR Text Key148266957
Report Number0001831750-2019-00592
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261639
UDI-Public07613327261639
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6506000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2019
Initial Date FDA Received06/17/2019
Supplement Dates Manufacturer Received05/20/2019
Supplement Dates FDA Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2018
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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