MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED

Catalog Number 6252000000

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Laceration(s) (1946); Injury (2348)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

The stair chair was immediately taken out of service as a precaution and checked by a third party service provider.No defect with the stair chair could be identified and the stair chair was returned to use by the user facility.The device was evaluated by a 3rd party service provider.

Event Description

It was reported that two emts were transporting a patient down some stairs when both emts fell.One received a minor cut, applied a band-aid, no medical intervention and was not seen by a doctor.The second emt received a rotator cuff injury and was seen by emergency room, received x-rays, and followed up with his employee health.The injured emt remains out of work.No injury to the patient was reported.

• Brand Name: STAIR PRO - MODEL 6252
• Type of Device: STRETCHER, HAND-CARRIED
• 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: 6727432
• MDR Text Key: 80659026
• Report Number: 0001831750-2017-00305
• Device Sequence Number: 1
• Product Code: FPP
• 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: 07/20/2017

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: 6252000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2010
• 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