MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNATIONAL REMOTE TELEMETRY MX40 MONITORING; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MX40

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 05/29/2019

Event Type  malfunction  

Event Description

The day following the lead replacement of a medtronic ppm the patient stated that his right inner arm went over and across the telemonitoring pack and the leads and he felt a "zap" sensation.He notified the nurse.The nurse picked up the monitor pack out of the patient's gown pocket to inspect the patient's concerns.The rn stated she heard a "zap" and felt an electrical shock run through her right thumb and up her right arm.The telepack was disconnected from the patient and arrangements were made to give to our biomed engineer.The transmitter device and lead-set was inspected by biomed for any tears, breaks, or cracks.Both pieces of equipment had no physical damage.The transmitter and lead set was tested for 15 minutes without duplication of any shocks or malfunctions.The transmitter was left running for an additional hour and then checked by touching it and moving the cables around.There was no resulting abnormal output or behavior from the transmitter.Philips medical dispatch was contacted and the service engineer picked up the unit from the hospital for inspection/evaluation at their factory.At this time the results are pending.Manufacturer response for remote telemetry transmitter pack, telemetry monitoring system (per site reporter): the device was returned to the philips medical service engineer.

• Brand Name: REMOTE TELEMETRY MX40 MONITORING
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS INTERNATIONAL; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8726931
• MDR Text Key: 148969785
• Report Number: 8726931
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Weight: 80