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

Catalog Number 6252000000

Device Problems Bent (1059); Break (1069); Component Falling (1105)

Patient Problem Fall (1848)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

It was reported that while the patient was being carried down, the left handle on the back of the chair suddenly broke and bent upwards.As a result of the sudden shift in weight, the right grip on the back of the chair broke as well.The patient allegedly fell onto the stairs and the paramedic standing behind the chair.The patient was not injured.Information regarding injury to the two paramedics was not reported.

Manufacturer Narrative

It is unknown if the product met specifications as the product was not evaluated by a stryker representative.With the alleged condition the product would not meet specifications.The customer did not wish to repair or inspect the device.The device was not made available for evaluation.

Event Description

It was reported that while the patient was being carried down, the left handle on the back of the chair suddenly broke and bent upwards.As a result of the sudden shift in weight, the right grip on the back of the chair broke as well.The patient allegedly fell onto the stairs and the paramedic standing behind the chair.The patient was not injured.Information regarding injury to the two paramedics was not 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: 7568492
• MDR Text Key: 110363410
• Report Number: 0001831750-2018-00517
• Device Sequence Number: 1
• Product Code: FPP
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• 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: 05/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2009
• 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