MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS REMOTE TELEMETRY PACKS; (INTELLIVIEW MX40)

Model Number MX40-1B4

Device Problem Battery Problem (2885)

Patient Problems Apnea (1720); Cardiac Arrest (1762)

Event Date 10/03/2014

Event Type  Death  

Event Description

A (b)(6) year old female s/p syncopal episode and fall with witnessed seizures - ruled out for traumatic injury.Admitted and placed on remote telemetry monitoring for observation and alcohol withdrawal protocol.The patient was monitored in atrial fibrillation with ventricular rate of 100 - 150.Approximately 24 hours after admission, on (b)(6) 2014, the patient was noted to be anxious and diaphoretic.The staff was made aware of one lead off at 23:23:30; the heart rate was 100.The monitor entered standby at 23:49:26 related to leads off.The nursing staff was notified of the leads off condition.A staff member re-applied the leads.At 23:54:58 the central station alerted the nurse to low battery.The nursing staff changed the battery.At 23:55:58 the central station was not receiving a signal.The central station confirmed a rhythm at 23:58:27 with a ventricular rate of 20.The nurse was alerted and entered the room to find the patient unresponsive.Resuscitation occurred and the patient transferred to icu for aggressive treatment with hypothermia, acidosis, and seizures.The patient was diagnosed with an anoxic brain injury and seizures.Life support was removed and the patient expired on (b)(6) 2014.Manufacturer notified of event and on site on (b)(6) 2014.Medical examiner case - autopsy results pending.

• Brand Name: PHILIPS REMOTE TELEMETRY PACKS
• Type of Device: (INTELLIVIEW MX40)
• Manufacturer (Section D): PHILIPS HEALTHCARE; 3000 minuteman rd.; andover MA 01810 109
• MDR Report Key: 4202589
• MDR Text Key: 4982120
• Report Number: 4202589
• Device Sequence Number: 1
• Product Code: MHX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2014

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: MX40-1B4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2014
• Distributor Facility Aware Date: 10/04/2014
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LITHIUM RECHARGEABLE BATTERY
• Patient Outcome(s): Death; Disability
• Patient Age: 52 YR
• Patient Weight: 82