MAUDE Adverse Event Report: AUDIO SERVICE GMBH AUDIO SERVICE BLUETOOTH TRANSMITTER; HEARING AID REMOTE CONTROL TRANSMITTER

Catalog Number 10420243

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

Hearing aid dispenser in (b)(6) informed audio service by phone that a patient asserted they received an electrical shock by touching the remote control bluetooth transmitter.The patient consulted a doctor because of problems with their heartbeat.Dispenser indicated in a follow-up phone call that the patient was absolutely fine and had no impairment of health.

Manufacturer Narrative

Investigation of the transmitter determined: visual inspection of all plugs, cables, sockets and housings of the transmitter, audio cable and power supply were undamaged.Output voltage of the usb plug measured 5.165v/dc.No higher voltage measured.Transmitter was switched on and the blue led was blinking correctly.Transmitter was connected to the power supply and the red led indicated correct charging process.The transmitter was paired via bluetooth with a rcu.The blue led blinked and after a few seconds the pairing was done correctly.An audio signal was delivered via an audio cable to the bluetooth transmitter.The audio signal was audible in a connected hearing aid.No evidence was found for causing an electric shock.It was not possible to duplicate the complaint.Further evaluation of the specifications indicates the transmitter does not have the potential to send out electrical energy to a patient when touching the transmitter.The internal voltage is a maximum 5v when connected to a charger, and 4.2v when a battery is used.An electrostatic shock is possible only if the device is connected to another device (e.G., tv set) where a connection to a power supply net exists.If an electrostatically charged person touches the transmitter, the energy from the person may be shortcutted via the tv cable to the power supply net.Although the transmitter is not affected, the person may get a non-hazardous electrostatic shock the same way as they would when getting close to the water tap or other conducting appliance.

• Brand Name: AUDIO SERVICE BLUETOOTH TRANSMITTER
• Type of Device: HEARING AID REMOTE CONTROL TRANSMITTER
• Manufacturer (Section D): AUDIO SERVICE GMBH; zeppelinstr. 9; herford 3205 1; GM 32051
• Manufacturer Contact: zeppelinstr. 9; herford 32051 ; 221380742
• MDR Report Key: 3701594
• MDR Text Key: 4332509
• Report Number: 3000246090-2014-00001
• Device Sequence Number: 1
• Product Code: PGQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 10420243
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention