MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO MP TRANSDUCER; SYSTEM, MONITORING, PERINATAL

Model Number	AVALON TOCO MP TRANSDUCER
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blister (4537)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
It was reported the patient developed blisters under the toco transducer.It was noted the customer did not use the transducer belt but used micropore tape to fix the transducer to the patient's abdomen.In addition, it was indicated the transducer was fixed in this position for 18 hours with no device position changes.Good faith efforts are being performed for further information.
Additional Manufacturer Narrative
Additional questions regarding the patient harm were not provided after several good faith effort attempts.It was indicated that there was no physical damage noted on the transducer.The instructions for use (ifu) for the avalon fetal monitor indicate, \"a patient possibly wears transducers for long periods without interruption.In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period.To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours.If the skin quality changes, move the transducer to another site.\"\ \ based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was the user.Based on the information available and results of additional analysis, no further action is necessary at this time.\ \ section e: reporting address postal: (b)(6).

• Brand Name: AVALON TOCO MP TRANSDUCER
• Common Device Name: SYSTEM, MONITORING, PERINATAL
• 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: 25133612
• Report Number: 9610816-2026-100871
• Device Sequence Number: 8661829
• Product Code: HGM
• UDI-Device Identifier: 00884838093218
• UDI-Public: (01)00884838093218
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2026

1 Device was Involved in the Event

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: AVALON TOCO MP TRANSDUCER
• Device Catalogue Number: 867248
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/10/2026
• Supplement Report FDA Received Date: 06/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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