MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6251; STRETCHER, HAND-CARRIED

Catalog Number 6251000000

Device Problems Device Slipped (1584); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  Injury  

Event Description

It was reported that the ankle restraint would not latch/lock due to a missing clip.The head end lift handle was broken and would not lock in place.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

New information received alleges that the patient alleges that the emts used a stair chair to remove him and in the process lost their grip and dropped him.The emts have reported that one of the handles broke.The patient alleges injury, further information regarding the alleged patient injury was not provided.

Event Description

It was reported that the restraints would not latch/lock and the head end lift handle broke, this allegedly injured the patient.Emts were transporting the patient from the house to the hospital.The patient alleges that the emts used a stair chair to remove him and in the process lost their grip and dropped him.The emts have reported that one of the handles broke.Further information regarding the alleged patient injury was not provided.

• Brand Name: STAIR PRO - MODEL 6251
• 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: 5187960
• MDR Text Key: 30252953
• Report Number: 0001831750-2015-00545
• 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: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6251000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2016
• 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