MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO XT; STRETCHER, WHEELED

Catalog Number 6506000000

Device Problem Positioning Failure (1158)

Patient Problem 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.16 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.6 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 22 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There was no patient involvement.

Manufacturer Narrative

The device that was pending was evaluated and it was determined the device experienced control/button function not functioning properly, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 21 to 20.

Event Description

This report summarizes 20 malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There was no patient involvement.

Manufacturer Narrative

(b)(4) device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.(b)(4) 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.(b)(4) device that was pending was evaluated and it was determined the device experienced erratic, bouncy cot raise or lower motion, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 22 to 21.(b)(4) device is still pending evaluation.

Event Description

This report summarizes (b)(4) malfunction events, where it was reported the devices experienced cot height cannot be adjusted or fowler cannot be lowered.There was no patient involvement.

• Brand Name: POWER-PRO XT
• 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: 18573298
• MDR Text Key: 333697728
• Report Number: 0001831750-2024-00227
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• 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,Followup
• Report Date: 04/29/2024

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: 6506000000
• 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; 01/01/2024
• Supplement Dates FDA Received: 04/02/2024; 04/29/2024
• 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