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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
Model Number 6100
Device Problem Device Fell (4014)
Patient Problems Bruise/Contusion (1754); Contusion (1787); Bone Fracture(s) (1870); Pain (1994)
Event Date 05/12/2020
Event Type  Injury  
Event Description
It was reported that the cot dropped down while transporting an incubator, which resulted in injuries to the paramedic.There was no patient involved at the time of the event.The paramedic obtained injuries to their arms, thighs, and face as well as a contusion and a fractured finger.
 
Manufacturer Narrative
The device was evaluated in the field and the issue was confirmed.The codes in section h have been updated to reflect this.
 
Event Description
It was reported that the cot dropped down while transporting an incubator, which resulted in injuries to the paramedic.There was no patient involved at the time of the event.The paramedic obtained injuries to their arms, thighs, and face as well as a contusion and a fractured finger.
 
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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
MDR Report Key10071413
MDR Text Key191449269
Report Number0001831750-2020-00626
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327261530
UDI-Public07613327261530
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 10/13/2020
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 Health Professional
Device Model Number6100
Device Catalogue Number6100003000
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 05/12/2020
Initial Date FDA Received05/19/2020
Supplement Dates Manufacturer Received05/12/2020
Supplement Dates FDA Received10/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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