MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MX-PRO R-3 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number 6082000000

Device Problems Break (1069); Continuous Firing (1123); Fire (1245); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the user facility is conducting training internally on proper placement of the o2 bottle to resolve the issue.

Event Description

It was reported that the ambulance crew had incorrectly placed the o2 bottle into the holder so that the regulator on the end of the d sized o2 bottle stuck out too far.When the crew loaded the cot into the ambulance, the regulator hit the bench seat and the regulator broke and somehow the o2 sparked and briefly caught fire.There were no adverse consequences to patients or users.It was reported that there was a delay in transport for the patient of about 15 minutes while another unit arrived on scene.The patient was in stable condition and there were no adverse consequences as a result of the delay.

• Brand Name: MX-PRO R-3 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7716073
• MDR Text Key: 115071905
• Report Number: 0001831750-2018-00868
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261547
• UDI-Public: 07613327261547
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6082000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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