MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME 5TH WHEEL STRETCHER 30IN; STRETCHER, WHEELED

Catalog Number 1105000030

Device Problem Mechanical Jam (2983)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

This report summarizes 7 malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage, brakes cannot be engaged or steer mechanism is difficult to engage/disengage.There was no patient involvement.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.6 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

The device that was pending was evaluated and it was determined the device experienced brake/steer pedal is inoperable; must use alternate pedal, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 7 to 6.

Event Description

This report summarizes 6 malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage or steer mechanism is difficult to engage/disengage.There was no patient involvement.

• Brand Name: PRIME 5TH WHEEL STRETCHER 30IN
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19154715
• MDR Text Key: 341519685
• Report Number: 0001831750-2024-00393
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278156
• UDI-Public: 07613327278156
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2024

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: 1105000030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 07/02/2024
• 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