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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIMEBIG WHEEL ELECT STRETCHER; STRETCHER, WHEELED

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STRYKER MEDICAL-KALAMAZOO PRIMEBIG WHEEL ELECT STRETCHER; STRETCHER, WHEELED Back to Search Results
Model Number 1115
Device Problem Mechanical Jam (2983)
Patient Problem Bone Fracture(s) (1870)
Event Date 12/28/2022
Event Type  Injury  
Event Description
It was reported that the device's brakes were difficult to engage.While attempting to use extra force to engage the brake, the nurse's foot slipped off the pedal and hit the floor.As a result, an x- ray was performed; she sustained a greenstick fracture and was placed in a walking boot.Additionally, she was given lifting and working limitations.Attempts are being made to gather additional details from the user facility.
 
Manufacturer Narrative
A visual and functional inspection was performed by a stryker field service technician.It was found that the brakes were difficult to engage/disengage.However, the alleged defect could not be confirmed.As a result, the unit involved in the alleged event was returned for further evaluation and replacement unit was sent to the customer.A stryker quality assurance engineer evaluated the unit with a procare operations representative.They determined that the brakes were difficult to engage due to the caster assembly being worn.The issue was resolved for the customer by sending a full unit replacement.
 
Event Description
It was reported that the device's brakes were difficult to engage.While attempting to use extra force to engage the brake, the nurse's foot slipped off the pedal and hit the floor.As a result, an x- ray was performed; she sustained a greenstick fracture and was placed in a walking boot.Additionally, she was given lifting and working limitations.
 
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Brand Name
PRIMEBIG WHEEL ELECT STRETCHER
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
marleca lane
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key16296568
MDR Text Key308775682
Report Number0001831750-2023-00281
Device Sequence Number1
Product Code FPO
UDI-Device Identifier07613327278217
UDI-Public07613327278217
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 06/23/2023
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 Model Number1115
Device Catalogue Number1115000000E
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/24/2023
Initial Date FDA Received02/03/2023
Supplement Dates Manufacturer Received01/24/2023
Supplement Dates FDA Received06/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2022
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) Other;
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