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

Model Number 1115

Device Problem Mechanical Jam (2983)

Patient Problems Inflammation (1932); Insufficient Information (4580)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that the brake/steer pedal is difficult to engage.It was further reported that a user sustained a foot injury.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that the brake/steer pedal is difficult to engage.It was further reported that a user sustained a foot injury.

Manufacturer Narrative

An investigation was completed, and a stryker quality assurance engineer spoke to the sales account manager, who explained that the customer was unable to identify the specific units involved.However, a stryker field service technician evaluated several units at the account and did find any component level defects or malfunctions.The device's brake being difficult to engage/disengage was likely not due to any component level defect or malfunction.Additionally, the caregiver had tendonitis in her foot and was on restrictions as a result of the injury.The issue was resolved by an ergonomic assessment being completed and the account working with the technician on how proper pedal usage/brake engagement.

• 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: 15315970
• MDR Text Key: 298857018
• Report Number: 0001831750-2022-00908
• 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: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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