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

Model Number	M2736A
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that a patient was burned by a avalon us transducer.Yes, device was in use on a patient at the time of the reported issue.Further details about the patient, such as age, height and weight had not been made available at the time of the reporting decision.
Additional Manufacturer Narrative
H10: a field service engineer went onsite to evaluate the device.Additional information was requested specifically regarding if the device failed to work as intended, how the issue was solved and how the device was cleaned and repositioned.No additional information was provided.The instructions for use (chapter: "repositioning transducers") recommend that the clinical staff make sure that the transducer is repositioned at least every three hours to prevent skin irritations.Furthermore it is mentioned that a cleaning or disinfecting agent should not remain on the transducer.Therefore customers are instructed to remove agent residues with a cloth dampened in water before applying a transducer to a patient (ifu chapter: "care and cleaning").No further contact was established by the customer regarding the reported device and issue, and the exact cause and resolution for the problem remain unknown.Due to the lack of available information, a malfunction of the device cannot be ruled out.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
• Common Device Name: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11222309
• Report Number: 9610816-2021-00021
• Device Sequence Number: 4037693
• Product Code: HGM
• UDI-Device Identifier: 00884838021488
• UDI-Public: (01)00884838021488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M2736A
• Device Catalogue Number: 989803171361
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other