MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000710

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

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

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The stryker account manager has been performing product training with the account.

Event Description

It was reported the back of the recliner recoiled rapidly, pushing a patient out of the chair and causing her to fall.No adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: TREATMENT RECLINER
• Type of Device: CHAIR, EXAMINATION AND TREATMENT
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7610591
• MDR Text Key: 111851788
• Report Number: 0001831750-2018-00597
• Device Sequence Number: 1
• Product Code: FRK
• 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
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3500000710
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• 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