MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M2735A SMART TOCO + TRANSDUCER

Model Number FFPH4505

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete; however, initial visual inspection identified that the case was cracked.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

The device was returned for evaluation as the device serial number was listed on the recall advisory.There was no device malfunction nor adverse event reported; however, initial visual inspection identified that the case was cracked.

Manufacturer Narrative

The complaint device was returned.Incoming visual inspection found that the case is cracked.Device evaluation identified that the case was cracked near the ecg connector.The ecg connector, flex circuit, and bottom and top covers were replaced.All parameter tests were all performed and passed.The cable, crystal, shake/rattle and final visual inspection passed as well.A root cause cannot be determined as there was no alleged malfunction; however, normal wear and tear most likely led to the casing issues.This type of event will continue to be monitored.Subsequent to the initial mdr, additional review of the hhe-2019-01 and hhe-2019-02 assessments have been conducted.The health care professional has concluded all fetal transducer products in relation to the resulted recall for both hhe's provided, do not qualify as reportable incidences; therefore, this malfunction should not have been submitted.

• Brand Name: PHILIPS M2735A SMART TOCO + TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• MDR Report Key: 9306880
• MDR Text Key: 167623542
• Report Number: 3007409280-2019-00085
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K140535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FFPH4505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1