MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON TOCO+ TRANSDUCER

Model Number	M2735A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that 3 patients in labor and delivery had experienced burns from using a philips fetal monitor.
Additional Manufacturer Narrative
The burn occurred form the sensor (tokos)(sp) placed on the patient¿s belly.A subsequent call from the customer indicated that these units were serviced by a third party not philips.They were sent to a third party for service and they received refurbished units in return.These are the units identified that caused the burns." follow up questions were sent multiple times by the philips technical consultant to find out additional details around alleged "burn like" marks, however, no additional information was provided to philips technical consultant requesting the data.It is unknown what the exact cause and resolution to the alleged issue are.Due to the lack of available information, a malfunction of the device cannot be ruled out.H3 other text : attempts to obtain additional information from the customer were not provided.
Event or Problem Description
It was reported that three (3) patients in labor and delivery had experienced burns from using our philips fetal monitor.The burn occurred form the sensor (tokos)(sp) placed on the patient¿s belly.

• Brand Name: AVALON TOCO+ TRANSDUCER
• Common Device Name: AVALON TOCO+ TRANSDUCER
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12624739
• Report Number: 9610816-2021-10420
• Device Sequence Number: 14365234
• Product Code: HGM
• UDI-Device Identifier: 00884838002715
• UDI-Public: 00884838002715
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: M2735A
• Device Catalogue Number: M2735A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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