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

Model Number 6506

Device Problems Misassembled (1398); Patient Device Interaction Problem (4001)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 05/20/2019

Event Type  malfunction  

Event Description

It was alleged that a user was injured due to in incorrectly installed hook that attaches to the safety bar.It was reported that the user had a broken finger.

Event Description

It was alleged that a user was injured due to in incorrectly installed hook that attaches to the safety bar.It was reported that the user had a broken finger.

• Brand Name: POWER PRO AMBULANCE COT
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8744673
• MDR Text Key: 149647206
• Report Number: 0001831750-2019-00599
• 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: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2018
• 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