MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT WORN DEVICE; TELEMETRY

Model Number M4841A

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 09/24/2017

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that a patient took leads off around 6:30 am on (b)(6) 2017.The staff realized the leads were off and placed the leads back on the patient.The staff believes the monitor was a significant factor to the death of the patient, because the central station was reading a false heart rhythm.The staff also believe that one of the cardiac leads was faulty, preventing any alarms from going off.The patient subsequently died at 7:00 am.

Manufacturer Narrative

Philips field service engineer (fse) went to the customer site but was unable to check the device in question.Risk management will not allow him to check the device.The customer's biomed stated to the fse that he checked the device and confirmed that it is working properly.The fse asked the biomed to have engineering check the bed in the room of the incident as the nurse stated that they saw 60 heartz cycle on the trace; no results of room testing were provided to philips.The fse gathered data logs from the central station.The customer provided patient strips.Additional information was requested from the customer, regarding additional strips, prior to the alleged incident timeframe.No further strips were provided.The customer initially indicated that the patient removed the ecg leads, further clarification from the risk manager, stated that the patient may have removed 1 lead, not all leads.The patient was monitored with easi 12 lead.The strips provided were reviewed by clinical and engineering experts who stated that there were pacer like spikes showing from the easi derived lead in the 2nd channel.The source of the signal in the 2nd lead of ecg could not be confirmed to be either from external interference in the patient room or from an internal or external pacemaker which would have not been providing capture.The presence of this 2nd lead allowed the system which was used in multi lead analysis mode to use both leads for the analysis of the rhythm which prevented the annunciation of rate related alarms as the heart rate slowed.Data logs collected indicate that the device was alarming at 07:21 -7:22am for ***v tach and ***asystole red alarms which silenced at the central station.No testing of the lead set used at the time of the alleged incident was performed.It is not known if pacing was set to on or off.The customer was provided resultant findings.We will consider the device remains at the customer site.The cause of the reported issue could not be determined.The staff believes the monitor was a significant factor to the death of the patient, because the central station was reading a false heart rhythm.The staff also believe that one of the cardiac leads was faulty preventing any alarms from going off.Testing of the device post incident by the customer's biomed found the telemetry to be working properly.Because the customer did not provide additional strip data requested, the cause of the reported issue could not be determined.Data logs do show that the device was monitoring for ***red alarm arrhythmia conditions and user interaction was noted.Malfunction could not however be ruled out.

• Brand Name: PATIENT WORN DEVICE
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6954107
• MDR Text Key: 89462908
• Report Number: 1218950-2017-07156
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4841A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 35 YR
• Patient Weight: 131