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

Catalog Number 6516000000

Device Problems Unintended Collision (1429); Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 07/05/2016

Event Type  Injury  

Event Description

It was reported that the ambulance was transporting a premature infant in an incubator that was attached to a power pro it to a medical facility for surgery, when the ambulance was struck in the side by another vehicle causing the ambulance to roll onto its side.It was reported that the infant was ejected out of the incubator during this event.It was reported that a pediatrician that was monitoring the infant patient was able to locate the infant after the vehicle came to a rest and started performing emergency breathing for the infant.It was reported that the infant was transported by rescue personnel for surgery.

• Brand Name: POWER PRO IT 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5936384
• MDR Text Key: 54201976
• Report Number: 0001831750-2016-00283
• 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
• Report Date: 08/11/2016

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: 6516000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2014
• 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