MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AV-TOCO MATERNAL PULS XDR

Model Number	453564435211
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that av-toco maternal puls xdr gives incoherent values.It unknown if the device was in use at time of event and no adverse event to the patient/user was reported.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that av-toco maternal puls xdr gives incoherent values.It unknown if the device was in use at time of event and no adverse event to the patient/user was reported.The customer contacted the customer care solution center (ccsc) to request a standard exchange for the defective av-toco maternal pulse xdr under their parts contract.Multiple good faith effort emails were sent in an attempt to confirm which values were inconsistent.However, no response has been received.No further information was provided the defective transducer was replaced under the customer parts contract as a standard exchange.The absence of further calls supports that the reported problem has not recurred or was resolved.
Additional Manufacturer Narrative
H3 other text: not returned.

• Brand Name: AV-TOCO MATERNAL PULS XDR
• Common Device Name: AV-TOCO MATERNAL PULS XDR
• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15077731
• Report Number: 9610816-2022-00388
• Device Sequence Number: 20162171
• Product Code: MHX
• UDI-Device Identifier: 00884838021471
• UDI-Public: 00884838021471
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110622
• 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,Followup
• Report Date (Section B): 07/21/2022

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: 453564435211
• Device Catalogue Number: 453564435211
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 11/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2016
• 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