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

Model Number M2736A

Device Problems Crack (1135); Electrical Shorting (2926); 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, initial visual inspection identified that the membrane was torn and 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 for evaluation.Incoming visual inspection identified that the case was cracked.Technical visual inspection found that the screw posts on the bottom case were broken.Device evaluation confirmed an issue because the device failed the ultrasound transducer electrical check.It was determined that the power board had an integrated circuit failure, there were loose crystal, and several damaged components on the main board.Three loose crystals were re-secured, internal capacitators, resistors and amps were replaced, and the top and bottom cases were replaced.The parameter, cable, crystal, and shake rattle tests were performed and passed.A definitive root cause could not be determined for the loose crystals, damaged capacitors, resistors and amplifiers; however, due to the case damage these are most likely due to the device being dropped and/or mishandled.This type of event will continue to be monitored.

• 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: 9176092
• MDR Text Key: 161860011
• Report Number: 3007409280-2019-00032
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Device Catalogue 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