MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M1356A US BELT/WIRE KNOB; TRANSDUCER

Model Number FFPH5505

Device Problems Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been received.The investigation is not yet complete; however, loose parts were heard inside.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

Reportedly, post repair, the customer reported the crystals were loose and the device was not picking up a signal.There was no report of patient involvement.No additional information is available.

Manufacturer Narrative

The complaint device was returned.Device evaluation identified that the ultrasound transducer electrical check and the safety, maintenance and calibration testing failed confirming the reported event.The device had loose crystals.The piezoelectric crystals were tightened.The parameter tests were performed and all passed.A definitive root cause for the low sounding crystals could not 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 M1356A US BELT/WIRE KNOB
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• MDR Report Key: 9305833
• MDR Text Key: 167621533
• Report Number: 3007409280-2019-00083
• 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: FFPH5505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1