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

Catalog Number 6082000000

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The patient initially stated that there was no injury and was fine but the user facility received a letter from the patient's attorney later alleging injury.The customer stated that they could not recreate the issue.

Event Description

It was reported that an elderly patient was on the cot and being unloaded at the hospital.The legs of the cot allegedly did not lower and the safety bar did not catch the safety hook and the cot dropped.The cot also allegedly tipped to the right side as it fell.

Manufacturer Narrative

The alleged issue has on-going legal matters and the device was not available for evaluation.Device was not available for evaluation.

Event Description

It was reported that an elderly patient was on the cot and being unloaded at the hospital.The legs of the cot allegedly did not lower and the safety bar did not catch the safety hook and the cot dropped.The cot also allegedly tipped to the right side as it fell.

• 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: 7477602
• MDR Text Key: 107196273
• Report Number: 0001831750-2018-00450
• 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,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6082000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/24/2008
• 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