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U.S. Department of Health and Human Services

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

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STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT - OBS; STRETCHER, WHEELED Back to Search Results
Catalog Number 6500000000
Device Problem Device Tipped Over (2589)
Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Pain (1994)
Event Date 06/29/2020
Event Type  Injury  
Event Description
It was reported that while transporting a (b)(6) patient, the patient shifted their weight while the cot was on the safety hook during unloading which resulted in the cot tipping over and the patient falling off the cot.The ems team was able to catch the patient who sustained no injuries from the event but a member of the ems team sustained an unknown injury.
 
Manufacturer Narrative
It was initially reported that the injury details were unknown.The user facility has provided details and b5 has been updated with the new information.
 
Event Description
It was reported that while transporting a 400lb patient, the patient shifted their weight while the cot was on the safety hook during unloading which resulted in the cot tipping over and the patient falling off the cot.The ems team was able to catch the patient who sustained no injuries from the event but a member of the ems team sustained a bruised foot and broken bone in their toe that required treatment.
 
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Brand Name
POWER PRO AMBULANCE COT - OBS
Type of Device
STRETCHER, WHEELED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10305556
MDR Text Key199864702
Report Number0001831750-2020-00643
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/07/2020
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? No
Device Operator No Information
Device Catalogue Number6500000000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/21/2020
Supplement Dates Manufacturer Received06/30/2020
Supplement Dates FDA Received10/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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