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

Catalog Number 3500000705

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

Repair components were sent to the customer as they elected to complete the repairs themselves.

Event Description

It was reported that the backrest wouldn't hold weight due to missing screws.No patient involvement and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: NARROW 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: 6400700
• MDR Text Key: 70065569
• Report Number: 0001831750-2017-00068
• 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: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 3500000705
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2009
• 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