MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) CLEARSIGN¿ AMPLIFIER FOR LABSYSTEM¿ PRO EP RECORDING SYSTEM; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number M0042002022R0

Device Problem Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the amplifier was exposed to high current.During preventative maintenance of a clearsign" amplifier for labsystem" pro ep recording system it was noted that the amplifier was exposed to too high current.The power supplied in the ep lab to the clearsign" amplifier was between was 240v-250v.Multiple errors in the system log were noted.The isolation transformer in the lab was modified to produce correct output (230 v).The clearsign" amplifier was exchanged.No patient involved.

• Brand Name: CLEARSIGN¿ AMPLIFIER FOR LABSYSTEM¿ PRO EP RECORDING SYSTEM
• Type of Device: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6106841
• MDR Text Key: 60040471
• Report Number: 2134265-2016-10155
• Device Sequence Number: 1
• Product Code: DRQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K150235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0042002022R0
• Device Catalogue Number: 2002022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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