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

Catalog Number 3500000710

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

Repair parts were sent to the customer and they will complete repairs.

Event Description

It was reported that the cross bar broke and allegedly caused the patient to fall (chair no longer supports patient weight, tips).There was patient involvement, however 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6397096
• MDR Text Key: 69994493
• Report Number: 0001831750-2017-00066
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• 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
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2012
• 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