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

Catalog Number 6252000000

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problems Bone Fracture(s) (1870); Skin Discoloration (2074); Injury (2348)

Event Date 08/31/2016

Event Type  Injury  

Event Description

It was alleged by the customer that during transport of a patient on a stair chair, the tracks locked out and the chair began descending a straight wood (uncarpeted) staircase.It was reported that the staff witnessed the chair run over the first two steps correctly then run out of control down the full flight of stairs.It was alleged that staff member 1 was dragged down the stairs, staff member 2 tried to slow the stair chair progress by running backwards, staff member 3 attempted to slow the descent, however all attempts to arrest the descent were not successful.It was alleged that the patient suffered minor bruising/grazing.One staff member received a broken leg, and one staff member received unidentified minor injuries.

Manufacturer Narrative

In response to this alleged event, a visual and functional inspection was performed by a field service representative.No defect was found with the unit and it was confirmed to be performing to specifications.Training was recommended to the account before the unit is put back into service.

Event Description

It was alleged by the customer that during transport of a patient on a stair chair, the tracks locked out and the chair began descending a straight wood (uncarpeted) staircase.It was reported that the staff witnessed the chair run over the first two steps correctly then run out of control down the full flight of stairs.It was alleged that staff member 1 was dragged down the stairs, staff member 2 tried to slow the stair chair progress by running backwards, staff member 3 attempted to slow the descent, however all attempts to arrest the descent were not successful.It was alleged that the patient suffered minor bruising/grazing.One staff member received a broken leg, and one staff member received unidentified minor injuries.

• 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: 5939129
• MDR Text Key: 54304728
• Report Number: 0001831750-2016-00284
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• 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?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2010
• 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