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

Model Number M-5463-01

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 02/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).After an afib ¿ paroxysmal procedure, it was reported two open blisters were discovered on the patient's lower back prior to discharge on the following day.It was reported the two blisters combined were 6 cm x 2 cm in diameter.Ointment and a bandage were administered to the patient.The patient was reported to be in stable condition.The equipment was tested and no issue found.The equipment was subjected to pm, safety and functional testing and all tests passed.The device history records 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.The customer complaint was not confirmed.

Manufacturer Narrative

On (b)(4), after following up with a bwi representative to clarify and obtain further information of complaints reported under this account, received information that the skin burn reported for this event was classified as a second degree.(b)(4).

Event Description

After an afib ¿ paroxysmal procedure, it was reported two open blisters were discovered on the patient's lower back prior to discharge on the following day.It was reported the two blisters combined were 6 cm x 2 cm in diameter.Ointment and a bandage were administered to the patient.The patient was reported to be in stable condition.

Manufacturer Narrative

Concomitant products used during the procedure: 1.Carto 3 system: model #: fg-5400-00m, serial #: (b)(4).2.Cool flow pump: model #: m-5491-02, serial #: (b)(4).Thermocool sf nav catheter: model #: unk, serial #: unk.4.Lasso eco nav catheter: model #: unk, serial #: unk.6.Soundstar catheter: model #: unk, serial #: unk.(b)(4).

• 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 ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3700779
• MDR Text Key: 11866251
• Report Number: 9612355-2014-00013
• 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,Followup
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/23/2014; 07/01/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention