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

Catalog Number FFPH4505

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

Reportedly, post repair the device was having case and cable issues.It is unknown if there was patient involvement.There was no report of patient harm.No additional information is available.

Manufacturer Narrative

The complaint device was returned.Device evaluation identified an internal short and broken screw posts.The us smart transducer belt knob, ecg connector, ecg flex circuit, case cover rubber gasket, bottom cover, and the plus top cover were replaced.The parameter tests were performed and all passed.A definitive root cause for the case and cable issues cannot be determined.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: 9212594
• MDR Text Key: 167627483
• Report Number: 3007409280-2019-00047
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FFPH4505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1