MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 10 LEAD ECG TRUNK AAMI/IEC 2M

Model Number M1663A

Device Problem Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

S reported while a patient was being monitored with continuous ecg monitoring, doctors had a wrong reading of the ecg signal.The customer reported it looks like the patient has been treated with the wrong therapy.There were no specific details provided about the event and what the alleged wrong therapy given to the patient at time of report.

Manufacturer Narrative

Multiple good faith efforts has been made to find out about the actual patient harm but no further information could be obtained.Tests of the device found that worn trunk cables resulted in artifact, which triggered vtach/vfib or asystole red alarms.Based on this ecg interpretation, the paramedics administered the first round of therapy.When the paramedics noted the monitor display and the patient¿s condition did not match, a 12-lead ecg was acquired with a different device, which revealed the patient was not in an arrhythmia.Further information on specific medications administered and therapies initiated was not available.Though typical advanced cardiovascular life support (acls) medications such as epinephrine and amiodarone are administered for the noted arrhythmias above and can induce adverse reactions, but it was indicated there was no harm to the patient.Although, the case was originally logged under the monitor but the defect is with the cable.As per the investigation done by the technician, the monitor had no malfunction but the cable.The device issue was resolved with the replacement of m1663a ecg trunk cable.The patient¿s current state remains unknown to philips.The engineer had replaced the m1663a ecg trunk cable and the defective m1663a ecg trunk cable was scrapped.Based on the information available and the testing conducted, the cause of the reported problem was due to a defective ecg trunk cable.The reported problem was confirmed.

Manufacturer Narrative

It has been confirmed the ecg artifact issue had no actual impact to patient and there was no harm to the patient nor intervention was required; however, the issue caused the operator to ¿consider¿ the situation critical for the patient.Tests of the device found that worn trunk cables resulted in artifact, which triggered vtach/vfib or asystole red alarms.Based on this ecg interpretation, the paramedics administered the first round of therapy.When the paramedics noted the monitor display and the patient¿s condition did not match, a 12-lead ecg was acquired with a different device, which revealed the patient was not in an arrhythmia.Further information on specific medications administered and therapies initiated was not available.Though typical advanced cardiovascular life support (acls) medications such as epinephrine and amiodarone are administered for the noted arrhythmias above and can induce adverse reactions, but it was indicated there was no harm to the patient.Although, the case was originally logged under the monitor but the defect is with the cable.As per the investigation done by the technician, the monitor had no malfunction but the cable.The device issue was resolved with the replacement of m1663a ecg trunk cable.The patient¿s¿ current state remains unknown to philips.The engineer had replaced the m1663a ecg trunk cable and the defective m1663a ecg trunk cable was scrapped.Based on the information available and the testing conducted, the cause of the reported problem was due to a defective ecg trunk cable.The reported problem was confirmed.

Event Description

It was reported while a patient was being monitored with continuous ecg monitoring, doctors had a wrong reading of the ecg signal.The customer reported it looks like the patient has been treated with the wrong therapy.There were no specific details provided about the event and what the alleged wrong therapy given to the patient was.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Type of Device: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; b1-3/d6; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; b1-3/d6; andover, MA 01810 ; 6172455900
• MDR Report Key: 17909676
• MDR Text Key: 325335972
• Report Number: 9610816-2023-00516
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 00884838010925
• UDI-Public: 00884838010925
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1663A
• Device Catalogue Number: M1663A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other