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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED
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STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED Back to Search Results
Catalog Number 6100003000
Device Problem Component Falling (1105)
Patient Problems Bone Fracture(s) (1870); Injury (2348)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
It was alleged that the safety hook missed the safety catch and the head part of the cot fell down from the ambulance to the floor.This event occurred with a patient, the patient was slightly injured at the elbow.A paramedic suffered a fracture on one hand.
 
Manufacturer Narrative
The cot was inspected by a stryker field service technician, with the customer.It was identified that the schnitzler safety hook that was added to the cot had been modified.This caused the safety hook to push up too early and miss the safety catch.It was identified that there were no additional defects found with the cot that would have caused or contributed to the alleged cot drop.The schnitzler safety hook is not manufactured by stryker.This complaint information was sent to the oem manufacturer schnitzler.
 
Event Description
It was alleged that the safety hook missed the safety catch and the head part of the cot fell down from the ambulance to the floor.This event occurred with a patient, the patient was slightly injured at the elbow.A paramedic suffered a fracture on one hand.
 
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Brand Name
M-1 COT - BASE HIGH LOAD 28
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 Key7127400
MDR Text Key95354765
Report Number0001831750-2017-00569
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 other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number6100003000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2013
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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