MAUDE Adverse Event Report: EXTERNAL MANUFACTURER ZOOM

Model Number	3120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an evaluation of this programmer was performed.At first, the programmer booted up with flickering backlight and then screen goes completely black.The inverter was shorted out on lower half and the inverter cover was badly melted.The liquid-crystal-display (lcd) cover was melted from inverter shorting out.The handle and front housing were cracked and the bottom housing¿s left post was broken off.Also, parts of the internal circuitry had a rear slide that was broken off, the strip chart recorder (scr) had cuts in print head from removing paper jam and the riser printed circuit board¿s gold pads had white fil that would not clean off.All affected components were replaced.The programmer passed all incoming tests.
Event or Problem Description
Boston scientific received information that this programmer was returned with no reported product performance issues.There was no patient involvement reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an evaluation of this programmer was performed.The programmer initially booted up with a flickering backlight, however, the screen went completely black.Analysis revealed that the inverter had shorted out on the lower half and the inverter cover was significantly melted.Furthermore, the liquid-crystal-display (lcd) cover was melted from the inverter shorting out.The handle and front housing were cracked and the bottom housing¿s left post was broken.In addition, parts of the internal circuitry had a rear slide that was broken, the strip chart recorder (scr) had cuts in the print head from removing paper jam and the riser printed circuit board¿s gold pads had white film that would not clean off.All affected components were replaced.After repair, the programmer passed all incoming tests.
Event or Problem Description
Boston scientific received information that the field representative could barely open this programmer.The programmer exhibited physical damage.However, the field representative got the programmer to function temporarily.The programmer was eventually returned for repair.There was no patient involvement reported.

• Brand Name: ZOOM
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7070248
• Report Number: 2124215-2017-20712
• Device Sequence Number: 1004621
• Product Code: LWS
• UDI-Device Identifier: 00802526582004
• UDI-Public: 00802526582004
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 3120
• Other Device ID Number: ZOOM LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1