MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM

Model Number FFPH5405

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 02/03/2020

Event Type  malfunction  

Event Description

Reportedly, post repair, the device was getting hot while on the charger.There was no patient involvement.

Manufacturer Narrative

The device was getting hot while on the charger.The complaint device was returned for evaluation.Incoming visual inspection found no anomalies.The device has no evidence of physical or cosmetic defects.Technical evaluation identified a main board circuit failure causing the unit to have low sounding crystals.The device was tested for over 24 hours with no evidence or findings of overheating.A parameter test was preformed and all tests passed.The customer complaint was confirmed as a main board failure was identified during device evaluation; however, the reported issue is not related to the device malfunction identified.The root cause for the main board failure was determined to be an integrated circuit failure resulting in weak sounds.A definitive root cause for the reported event could not be determined as a there was no evidence or findings related to the device overheating.The main board circuit was repaired and the device passed the ultrasound transducer electrical check.The device was repaired and returned to the customer.No further investigation is required.

• Brand Name: PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM
• Type of Device: CORDLESS FETAL TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; nederland b.v.; postbus 10.000; da best 5680 ; NL 5680
• MDR Report Key: 9771197
• MDR Text Key: 181554535
• Report Number: 3007409280-2020-00042
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K023931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FFPH5405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1