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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
Model Number 6506
Device Problem Device Tipped Over (2589)
Patient Problems Bone Fracture(s) (1870); Sprain (2083)
Event Date 02/13/2020
Event Type  Injury  
Event Description
It was reported that a patient was being unloaded from the ambulance.The patient was in the seated position with the fowler up and restrained by all cot restraints.The customer alleges there were two operators on the cot both on the head end of the cot.The customer stated that the patient was larger and shifted their weight to the patient left side and the cot tipped to that side.Allegedly the patient broke their wrist and an operator received a wrist sprain as a result of this incident.The cots safety bar remained caught on the safety hook of the ambulance and prevented the cot from hitting the floor.
 
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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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key9813435
MDR Text Key182805711
Report Number0001831750-2020-00311
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
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number6506
Device Catalogue Number6506000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/13/2020
Initial Date FDA Received03/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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