MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6506 MTS PWRPRO COT MID CONFIG; STRETCHER, WHEELED

Model Number 6506

Device Problems Difficult or Delayed Positioning (1157); Device Tipped Over (2589)

Patient Problems Abrasion (1689); Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that the cot missed the safety hook and the cot tipped onto it's side.It was further reported that the patient injured their elbow.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that the cot missed the safety hook and the cot tipped onto it's side.It was further reported that the patient received an abrasion to their elbow.

Manufacturer Narrative

The user facility confirmed that the injury to the patient was a small abrasion to the elbow, and no treatment was needed.

• Brand Name: 6506 MTS PWRPRO COT MID 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14735099
• MDR Text Key: 294287812
• Report Number: 0001831750-2022-00594
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327513264
• UDI-Public: 07613327513264
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6506
• Device Catalogue Number: 650605550002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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