MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6507 POWER PRO 2, HIGH CONFIG; STRETCHER, WHEELED

Catalog Number 650705550001

Device Problem Positioning Failure (1158)

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

Event Date 10/01/2023

Event Type  malfunction  

Event Description

This report summarizes 32 malfunction events, where it was reported the devices experienced cot height cannot be adjusted, false engagement of handle in the upright or horizontal position, or fowler cannot be lowered; stuck in raised/elevated position.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.27 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.4 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 31 malfunction events, where it was reported the devices experienced cot height cannot be adjusted, false engagement of handle in the upright or horizontal position, or fowler cannot be lowered; stuck in raised/elevated position.There was no patient involvement.

Manufacturer Narrative

3 devices that were pending evaluation were evaluated in the field and the issue was confirmed.The devices were repaired on site and returned to service.1 device that was pending evaluation was a duplicate record so was removed.Section h codes have been updated to reflect this.

• Brand Name: 6507 POWER PRO 2, HIGH CONFIG
• 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: 18573489
• MDR Text Key: 333625746
• Report Number: 0001831750-2024-00243
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327559118
• UDI-Public: 07613327559118
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 31
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 650705550001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 01/01/2024
• Supplement Dates FDA Received: 03/28/2024
• 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