MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EVACUATION CHAIR - MODEL 6254; STRETCHER, HAND-CARRIED

Catalog Number 6254000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 03/10/2016

Event Type  Injury  

Event Description

It was reported that allegedly an employee was hurt when taking the chair off the wall during a training at the hospital.Further information has not been provided at this time.

Manufacturer Narrative

It was reported by the customer that an employee reported a back strain due to the chair opening when removing it from the wall mount.It was not reported if the alleged injury required any medical intervention.It was also reported that the chair was likely not latched properly when put away by the previous user.There was no alleged defect with the device and it was confirmed that the device had been returned to service.

Event Description

It was reported that allegedly, an employee was hurt when taking the chair off the wall during a training at the hospital.

• Brand Name: EVACUATION CHAIR - MODEL 6254
• 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: 5552107
• MDR Text Key: 42009855
• Report Number: 0001831750-2016-00115
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6254000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: No
• 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