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

Model Number	M1663A
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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.
Additional Manufacturer Narrative
D4 unique device identifier (udi) was corrected to no information as the customer was unable to provide the device identifier.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Common Device Name: 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
• Report Number: 9610816-2023-00516
• Device Sequence Number: 15112244
• Product Code: DRX
• UDI-Device Identifier: 00884838010925
• UDI-Public: 00884838010925
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1663A
• Device Catalogue Number: M1663A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 12/15/2023; 01/17/2024; 07/09/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/12/2024; 01/17/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown