MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH PHILIPS M2736A AVALON U/S TRANSDUCER

Model Number FFPH5505

Device Problems Loss of or Failure to Bond (1068); Crack (1135); 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.A follow-up report will be submitted upon completion of the device evaluation.

Event Description

Reportedly, post repair, the device has a broken case, loose parts inside or possibly broken crystals.There was no report of patient involvement.No additional is information available.

Manufacturer Narrative

The complaint device was returned for evaluation incoming visual inspection found no anomalies; however, loose parts were heard inside.Technical visual inspection found no anomalies.Device evaluation found the ultrasound electrical check failed confirming the reported crystal issue.The report of the cracked case was refuted.There were three crystals that were re-secured.The broken internal components (capacitator, resistors and amps) were replaced.The ultrasound electrical check test was re-ran and passed.The root cause for the loose crystals was most likely due to the adhesive not curing properly and the device may have been dropped.This type of event will continue to be monitored.Device code 1135 removed - correction.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 M2736A AVALON U/S TRANSDUCER
• Type of Device: TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH; hewlett-packard-str.-2; boeblingen, 71034 ; GM 71034
• MDR Report Key: 9214529
• MDR Text Key: 167627318
• Report Number: 3007409280-2019-00052
• 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,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 09/19/2019
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1