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

Catalog Number 6252000000

Device Problem Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Pain (1994); Muscle/Tendon Damage (4532)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

The user facility evaluated their device and performed repairs.

Event Description

It was reported that while transporting a patient down a flight of stairs the track support broke, causing the stair chair to collapse.As a result, the patient had bruises on their left arm, the medic at the head end of the chair sprained their finger, and the medic at the foot end of the chair strained their back.It was further reported that the fire department had to come transport the patient, which may have caused a delay, but further details are unknown at this time.The patient and medics were x-rayed and received treatment at the hospital.The severity of the injuries and type of treatment received is currently unknown and attempts are being made to gather this information from the user facility.

Manufacturer Narrative

It was initially reported that more details were being gathered regarding the delay and type of treatment received by the medics.Multiple attempts were made to the customer to gather more details; however, they stated they were unable to provide any other information.Section b5 has been updated.H3 other text: user facility performed the device evaluation and required no further action.

Event Description

It was reported that while transporting a patient down a flight of stairs the track support broke, causing the stair chair to collapse.As a result, the patient had bruises on their left arm, the medic at the head end of the chair sprained their finger, and the medic at the foot end of the chair strained their back.It was further reported that the fire department had to come transport the patient, which may have caused a delay.The patient and medics were x-rayed and received treatment at the hospital.Attempts were made to the customer to gather more information regarding the delay and type of treatment the medics received; however, the customer was unable to provide more details.

• 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
• MDR Report Key: 11628167
• MDR Text Key: 244210889
• Report Number: 0001831750-2021-00674
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other