MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL BASE STATION; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number	AVALON CL BASESTATION
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the avalon cl basestation is intermittently switching from normal heartbeat.The device was in use on a patient at the time of the event.There was no adverse event reported.
Additional Manufacturer Narrative
The philips remote service engineer (rse) spoke to the customer biomed who advised that the device was intermittently switching from a normal heartbeat.The rse tried to clarify the customer allegation and requested additional information from the biomed.The biomed stated that they believed there was a tone difference when the device switched to a us sound but also stated that the evidence of issue is hard to gather.The rse advised the biomed to gather further information (i.E video, photos of issue) and also provided the biomed the base station manual to see if anything in the manual could point to what they are describing.The rse also suggested to change the scalp electrode or transducers (in case of damage) to see if we can narrow down the reported issue.Currently it is suspected that the issue is a one-off event.The customer will call back if additional information is gathered at next event.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting institution phone # (b)(6).Reporter phone # (b)(6).

• Brand Name: AVALON CL BASE STATION
• Common Device Name: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• 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: 24315998
• Report Number: 9610816-2026-100265
• Device Sequence Number: 5676756
• Product Code: DRG
• UDI-Device Identifier: 00884838034228
• UDI-Public: (01)00884838034228
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140535
• 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: AVALON CL BASESTATION
• Device Catalogue Number: 866074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2020
• 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