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

Model Number	M2735A
Medical Device Problem Code	Failure to Transmit Record (1521)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.(b)(6).
Event or Problem Description
The customer reported that the maternal pulse is temporarily even hourly not transmitted and there was an emergency c-section in labor room 7.The device was in use on a patient and there was report of patient harm.
Additional Manufacturer Narrative
Requests for information were made through good faith effort (gfe).But the information available so far is insufficient to state that the toco+ is not compatible with the fetal monitor or a toco+ that does not measure the maternal pulse when the client claims that the nurse used the wrong toco+.It was not possible to confirm whether or not there was a failure.The resolution is unknown at this time.H3 other text : device not returned.
Event or Problem Description
The customer reported that the maternal pulse is temporarily even hourly not transmitted and there was an emergency c-section in labor room 7.The device was in use on a patient and there was report of patient harm.It was asked if the reported problem caused any real damage or injury to the patient or if a possible damage was related to the use of the device, but the answer was asku (asked but unknown).

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15975531
• Report Number: 9610816-2022-00629
• Device Sequence Number: 15202934
• Product Code: HGM
• UDI-Device Identifier: 00884838002715
• UDI-Public: 00884838002715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Biomedical Engineer
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 03/27/2023
• 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: Required Intervention
• Patient Sex: Unknown