MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)

Model Number	SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the adapter cable has intermittent issues where the saturation monitor displays a low or high heart rate values (between 20¿220) while spo2 value is displayed correctly.But when ecg is connected, the heart rate level is normal.The device was in clinical use.There was no report of patient or user harm.
Additional Manufacturer Narrative
Analysis was performed by remote service personnel.The remote support engineer (rse) talked to the customer and confirmed the details about the cables used.The customer reported that they did not see issue like this with adapter cables manufactured at another manufacturer date.The results of the analysis were that the customer was advised to replace the defective cables with new one.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 defective spo2 adapter cable.The issue was resolved by advising the customer to replace the defective cable with new one from another manufacturer date and lot/batch.E1: reporting institution phone #: (b)(6).E1: reporter phone #: (b)(6).

• Brand Name: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Common Device Name: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 24313302
• Report Number: 9610816-2026-100262
• Device Sequence Number: 20049264
• Product Code: DQA
• UDI-Device Identifier: 00884838082595
• UDI-Public: (01)00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K032979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN)
• Device Catalogue Number: 989803128651
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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