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

Catalog Number 6252000000

Device Problems Failure To Adhere Or Bond (1031); Sticking (1597)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

It was reported that the tracks were stuck / binding and would not engage stairs.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was found that the tracks were difficult to operate, however would still engage stairs.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was found that the tracks were difficult to operate, however, would still engage stairs.The device would still be able to function for transport of a patient.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4901758
• MDR Text Key: 6024217
• Report Number: 0001831750-2015-00328
• 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: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2015
• 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