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

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.

• 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 Key: 16296568
• MDR Text Key: 308775682
• Report Number: 0001831750-2023-00281
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278217
• UDI-Public: 07613327278217
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Number: 1115
• Device Catalogue Number: 1115000000E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/03/2023
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other