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

Catalog Number 6252000000

Device Problems Bent (1059); Collapse (1099)

Patient Problem Injury (2348)

Event Date 06/08/2016

Event Type  malfunction  

Event Description

It was alleged by the customer that the device collapsed on the stairs during patient transport, injuring a patient and a paramedic.It was alleged that the device frame is now bent.Further information regarding the patient and user injuries was not provided.

Manufacturer Narrative

It was reported that the event resulted in minor injuries to the patient and paramedic.Neither alleged injury required medical intervention.A visual and functional inspection was performed by the stryker field service representative where it was identified that the event was due to the track belt needing adjustment.The customer performed the required repair on the device.

Event Description

It was alleged by the customer that the device collapsed on the stairs during patient transport, injuring a patient and a paramedic.

• 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: 5726800
• MDR Text Key: 47450746
• Report Number: 0001831750-2016-00199
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2010
• 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