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

Catalog Number 6506000000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

Patient Problem Fall (1848)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

It is reported a ct scan was performed on the patient.The ct scan was precautionary and that no injury was reported due to the alleged event.It was reported by the customer that this issue was caused by user error and that additional product training was offered to the customer.This additional training was declined.

Event Description

It is alleged that while pulling the cot out of the ambulance with a patient on-board, an employee thought that the cot was going to miss the safety hook.The employee is alleged to have grabbed the side of the cot, and it is reported this resulted in the patient being tipped over.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It is alleged that while pulling the cot out of the ambulance with a patient on-board, an employee thought that the cot was going to miss the safety hook.The employee is alleged to have grabbed the side of the cot, and it is reported this resulted in the patient being tipped over.

• 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: 6838870
• MDR Text Key: 84938468
• Report Number: 0001831750-2017-00370
• Device Sequence Number: 1
• Product Code: FPO
• 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: 03/29/2018

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?: No
• Device Operator: No Information
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 08/04/2017
• Supplement Dates FDA Received: 03/29/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2016
• 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