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

Catalog Number 1115000000E

Device Problem Mechanical Jam (2983)

Patient Problems Pain (1994); Muscle/Tendon Damage (4532); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.11 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.13 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 24 malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage, steer mechanism is difficult to engage/disengage, or brakes cannot be engaged.There were 2 events with patient involvement; the patients experienced muscle/tendon damage;pain.

Manufacturer Narrative

2 devices that were pending were evaluated in the field but the issues were not confirmed; no defect or malfunction was found.8 devices that were pending were evaluated with a model variant in the field but the issues were not confirmed; no defect or malfunction was found.1 device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated.Because of this, the number of reported events has been changed from 24 to 20.

Event Description

This report summarizes 20 malfunction events, where it was reported the devices experienced brakes difficult to engage disengage, steer mechanism is difficult to engage disengage, or brakes cannot be engaged.There were 2 events with patient involvement; the patients experienced muscle tendon damage; pain.

• Brand Name: PRIME ELECTRIC BIG WHEEL 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18562816
• MDR Text Key: 333462962
• Report Number: 0001831750-2024-00071
• 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: 20
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1115000000E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/01/2024
• 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