MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LOWBACK CHAIR W/O ARMS 18IN; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000220

Device Problems Crack (1135); Unintended System Motion (1430)

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

Event Date 10/20/2014

Event Type  malfunction  

Event Description

It was reported that the frame of the chair is cracked and may not be able to support patient weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The unit could not repaired in the field and needed to be replaced.

• Brand Name: LOWBACK CHAIR W/O ARMS 18IN
• 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: 4258173
• MDR Text Key: 5105949
• Report Number: 0001831750-2014-03362
• 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: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3500000220
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/20/2014
• 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