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

Catalog Number 6252000000

Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)

Patient Problems Pain (1994); Muscle/Tendon Damage (4532); Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported that during a patient transport, the unit was difficult to maneuver which does not result in a tip.It was further reported that one user reported a shoulder injury and another user reported a knee injury.Attempts are being made to gather additional injury and treatment details from the user facility.

Manufacturer Narrative

It was reported during patient transport, the chair was difficult to maneuver and that the chair had dropped, resulting in two caregivers being injured.One caregiver partially dislocated their shoulder and went to see a doctor to pop it back in place and was advised to take time off work and take ibuprofen.The other caregiver sprained their knee and saw a doctor, they were advised to ice it, rest, and take ibuprofen.

Event Description

It was reported that the device unexpectedly dropped/collapsed.It was further reported that as a result, 1 user sustained a shoulder injury and another user sustained a knee injury.Additionally, the unit was difficult to maneuver as a result of the drop.

• 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: melissa millard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13970187
• MDR Text Key: 288378948
• Report Number: 0001831750-2022-00279
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other