MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM; ACCESSORY

Model Number	3140
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
Boston scientific received information that this zoom wireless transmitter had a popping sound and then sparks came out from the connection during a patient check.A burning smell occurred was observed.The product remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an evaluation was performed and showed that the allegation against the zoom wireless transmitter (zwt) was not confirmed.The returned zwt was successfully connected with a known good programmer and interrogated the laboratory medical implant communication service (mics) band pulse generator.A successful product return test was also executed through the serial port of the zwt.

• Brand Name: ZOOM
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7393648
• Report Number: 2124215-2018-04954
• Device Sequence Number: 19161211
• Product Code: OSR
• UDI-Device Identifier: 00802526562501
• UDI-Public: 00802526562501
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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
• Operator of Device: Other
• Device Model Number: 3140
• Other Device ID Number: ZOOM WIRELESS TRANSMITTER (ZWT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 06/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1