MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Catalog Number 6100003000

Device Problems Component Falling (1105); Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 06/05/2018

Event Type  malfunction  

Event Description

It was reported that during unloading of the cot, the cot dropped down with patient on it.The chassis was jammed during lifting and the paramedic jarred his wrist.A preventive check-up of the patient in the hospital was also performed.No further details were provided.

Manufacturer Narrative

It was reported that no medical treatment was needed for the paramedic.The patient had a preventative check-up in the hospital, and was not injured.Device evaluated by 3rd party service.

Event Description

It was reported that during unloading of the cot, the cot dropped down with patient on it.The chassis was jammed during lifting and the paramedic jarred his wrist.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• 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: 7618495
• MDR Text Key: 112173673
• Report Number: 0001831750-2018-00603
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261530
• UDI-Public: 07613327261530
• Combination Product (y/n): N
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• 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