MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

It was reported that while a patient underwent an ablation procedure with a stockert 70 system an electrocardiogram (ecg) noise interference event occurred.Shortly after the physician placed the ecg leads and location patches on the patient, noise appeared on all channels, intercardiac (ic) and body surface (bs), and the interference occurred on the anesthesia monitor and defibrillator.The procedure was completed without patient consequence by replacing the stockert generator.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: carto 3 system, serial# unk.(b)(4).Manufacture¿s reference no.: (b)(4).The hardware investigation has begun but it has not been completed at this time.

Manufacturer Narrative

Evaluation summary: (b)(4).It was reported that while a patient underwent an ablation procedure with a stockert 70 system an electrocardiogram (ecg) noise interference event occurred on all channels, intercardiac (ic) and body surface (bs), and the interference occurred on the anesthesia monitor and defibrillator.The device was evaluated and the complaint could not be duplicated.The d-sub connector was broken.The defected part was replaced and the issue was resolved.The device was also subjected to pm, safety and functional testing and all tests passed.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4352583
• MDR Text Key: 16630878
• Report Number: 9612355-2014-00059
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Other Device ID Number: (1)4260166370195
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1