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

Catalog Number 6506000000

Device Problem Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/14/2023

Event Type  Injury  

Event Description

It was reported that the practioners finger was fractured when the device dropped on their finger while unloading.Further information has not been provided.

Manufacturer Narrative

The device that was originally reported was reported in error.The correct device catalog number, serial number, and gtin number have been updated in section d4.This complaint investigation is still ongoing and further information will be provided.

Event Description

It was reported that the practioners finger was fractured when the device dropped on their finger while unloading.Further information has not been provided.

Manufacturer Narrative

The user received a fractured finger and time off of work to recover.A visual and functional inspection was performed by a field service technician who identified the event was due to a damaged communication board.

Event Description

It was reported that the practioners finger was fractured when the device dropped on their finger while unloading.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17701770
• MDR Text Key: 322877141
• Report Number: 0001831750-2023-00997
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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
• Patient Outcome(s): Other