MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME BIG WHEEL STRETCHER 30"; STRETCHER, WHEELED

Catalog Number 1115000030

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced brakes difficult to engage/disengage and false latch of siderail.There was no patient involvement.

• Brand Name: PRIME BIG WHEEL STRETCHER 30"
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17990656
• MDR Text Key: 327257994
• Report Number: 0001831750-2023-01115
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278330
• UDI-Public: 07613327278330
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1115000030
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2023
• Initial Date FDA Received: 10/23/2023
• 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