MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 6083 AMBULANCE COT; STRETCHER, WHEELED

Catalog Number 6083000000

Device Problems Component Falling (1105); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 06/29/2017

Event Type  Injury  

Manufacturer Narrative

The injured emt received an mri and required physical therapy for the muscular back injury.A visual and functional inspection was performed by a stryker field service representative who could not identify any component level defects or malfunctions that would have caused or contributed to the alleged event.This issue was resolved for the customer by inspecting the unit, ensuring proper functionality, and returning it to use.

Event Description

It was reported that while unloading a (b)(6) patient, the cot legs allegedly did not lock and the cot dropped.The alleged event reportedly caused the user at the foot end of the cot to try to support the (b)(6) patient so that the cot would not drop fully.It was reported that as a result of this alleged event, the user received lower back and leg pain and the patient was uninjured.

• Brand Name: 6083 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: 6904630
• MDR Text Key: 87783545
• Report Number: 0001831750-2017-00425
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6083000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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