MAUDE Adverse Event Report: Philips Medical Systems ECG Electrodes; DETECTOR AND ALARM, ARRHYTHMIA

Model Number	CBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a cbl ecg 5 lead grabber aami + spo2, tele indicating the lead set was not working and was unable to provide appropriate rhythm; the readings were inaccurate.The device was in clinical use at the time the issue was discovered.There was no adverse or patient harm reported.
Additional Manufacturer Narrative
A philips contract administrator (ca) worked with the customer.It was determined that the cable needed to be replaced.Based on the results of the analysis, it was determined that the product has malfunctioned and the most likely cause of the reported problem was a faulty cable.A replacement cable was sent to resolve the issue.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.If additional information is received, the complaint file will be reopened for further investigation.

• Brand Name: ECG Electrodes
• Common Device Name: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): Philips Medical Systems; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; +1(617)245-5900
• MDR Report Key: 50931739
• Report Number: 1218950-2026-100672
• Device Sequence Number: 13451654
• Product Code: DSI
• UDI-Device Identifier: 00884838013407
• UDI-Public: (01)00884838013407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CBL ECG 5LEAD GRABBER, AAMI + SPO2, TELE
• Device Catalogue Number: 989803171851
• Device Lot Number: 1125
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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
• Patient Sex: Unknown