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 Problem Pain (1994)

Event Date 01/26/2016

Event Type  Injury  

Manufacturer Narrative

A visual and functional inspection was performed by the field service representative who reported that there was no defect that would have caused or contributed to the alleged event.

Event Description

It was reported by the customer that as the patient was seated on the cot, two hospital staff members and two emts were lifting the cot.The hospital staff members lifted the cot more quickly than the emts, causing the cot to tip over away from the hospital staff.The patient reported pain in their back, neck and elbow as a result of the alleged cot tip.It was not reported if any medical intervention was required.A visual and functional inspection was performed by the field service representative who reported that there was no defect that would have caused or contributed to the alleged event.

• 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: 5457756
• MDR Text Key: 38960634
• Report Number: 0001831750-2016-00064
• 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: 01/27/2016

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: 6082000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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