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

Catalog Number 6252000000

Device Problem Device Fell (4014)

Patient Problem Pain (1994)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported that the stair tracks folded in during patient transport, resulting in a shoulder injury to the caregiver.The reporter advised the caregiver had an mri performed, but no further details about the injury have been provided.Additional information about the injury has been requested.The patient was not injured as a result of the event.The device was inspected by a stryker service technician; no defect was found with the product that could have contributed to the reported malfunction.

Event Description

It was reported that the stair tracks folded in during patient transport, resulting in a shoulder injury to the caregiver.The reporter advised the caregiver had an mri performed.The injury was reported have required surgeries and physical therapy.The patient was not injured as a result of the event.The device was inspected by a stryker service technician; no defect was found with the product that could have contributed to the reported malfunction.

Manufacturer Narrative

Future complaints will continue to be monitored for trends.

• 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: 10521769
• MDR Text Key: 206530945
• Report Number: 0001831750-2020-00902
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other