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

Catalog Number 6082000000

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

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870)

Event Date 12/15/2013

Event Type  Injury  

Event Description

It was reported that during transporting a patient the cot caught some salt on the road and tipped over.As a result of the tip event the patient's collar bone was broken and their arm was bruised.The user facility stated that the event was operator error as the emts were pushing the cot side ways while the unit was in the highest height position.The cot involved in the event had no alleged malfunction and did not cause or contribute to this event as it was operator error as reported by the user facility.The user facility reported that they have taken action with the emts about proper transporting procedures.The cot was also not damaged as a result of the tip event and did not require repair.The user facility was unable to identify the serial number of the cot but confirmed that it was a 6082 model.

• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3571721
• MDR Text Key: 4218927
• Report Number: 0001831750-2014-00362
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2013

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: Other
• Device Catalogue Number: 6082000000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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