MAUDE Adverse Event Report: GBO MEDIZINTECHNIK AG CHATTANOOGA; MONODE

Model Number 02200002

Device Problems Loose or Intermittent Connection (1371); Device Emits Odor (1425); Smoking (1585)

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

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Complaint received from customer that alleges "monode smoking, has a burning smell".Questionnaire was not received from clinician and/or pt.Device not returned to manufacturer for eval.No indication event caused or contributed to permanent impairment or death.No indication device caused or contributed to the event.

Manufacturer Narrative

Fda acknowledged recall #z-0121-2016 in process as a result of this and similar incidences.

• Brand Name: CHATTANOOGA
• Type of Device: MONODE
• Manufacturer (Section D): GBO MEDIZINTECHNIK AG; kleistrasse 6; rimbach C-646 68
• Manufacturer (Section G): GBO MEDIZINTECHNIK AG; kleiststrasse 6; rimbach C-646 68
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 4861665
• MDR Text Key: 5812699
• Report Number: 9616086-2015-00015
• Device Sequence Number: 1
• Product Code: IMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0883433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

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: Health Professional
• Device Model Number: 02200002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other