MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON

Model Number M2736A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that there were "burn like" marks noted on patient skin where ultrasound transducer was positioned.The device was used for patient monitoring at the time of the alleged malfunction.

Manufacturer Narrative

H10: customer was reminded of the information from the instructions for use (ifu) on the ultrasound tranducer(s) repositioning.Follow up questions were sent multiple times by the philips field service engineer (fse) to find out additional details around alleged "burn like" marks, however, no additional information was provided to philips fse requesting the data.It is unknown what the exact cause and resolution to the alleged issue are.If and when the customer proceeds with providing the requested follow up data required for the investigation, this complaint will be re-opened.And evaluation performed.Philips fse removed the ultrasound transducer from the field and replaced it with the new ultrasound transducer.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALON
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11066600
• MDR Text Key: 225779833
• Report Number: 9610816-2020-00471
• Device Sequence Number: 1
• Product Code: HGM
• Combination Product (y/n): N
• PMA/PMN Number: K062137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2736A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1