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

Catalog Number 6252000000

Device Problem Device Fell (4014)

Patient Problems Asthma (1726); Laceration(s) (1946); No Information (3190)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

It was reported that the handle on the chair broke while transporting a patient and that the patient suffered an unspecified injury as a result.Further details regarding the injury and/or treatment have not been provided.

Manufacturer Narrative

The investigation has been completed.The investigation identified that this event resulted in a minor injury rather than a serious one, the section h codes have been updated to reflect this.

Event Description

It was reported that the handle on the chair broke while transporting a patient and that the patient suffered a small laceration to the neck as a result.It was reported that the neck was stabilized as a precaution but no neck injury beyond the laceration was reported.It was reported that the event triggered the patient's asthma which was treated with oxygen.The unit was evaluated and repaired by stryker field service.

• 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: 11055115
• MDR Text Key: 223066788
• Report Number: 0001831750-2020-01222
• 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
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other