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

Catalog Number 6500000000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589)

Patient Problems Death (1802); Injury (2348)

Event Date 05/10/2015

Event Type  Death  

Manufacturer Narrative

Device not available.

Event Description

It was alleged that the patient suffered injuries and her eventual death when a stretcher she was being transported on tipped over in a parking lot area.It was alleged that the ems facility failed to observe the condition of the surface upon which the stretcher was being navigated.It was alleged that the wheel became caught in the pavement and the stretcher tipped over with the patient still strapped to the stretcher.

• Brand Name: POWER PRO AMBULANCE COT - OBS
• 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: 6609601
• MDR Text Key: 76586697
• Report Number: 0001831750-2017-00219
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2017

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: 6500000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2010
• 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