MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER

Model Number	M2736A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporter information: (b)(6).
Event or Problem Description
It was reported after using the ultrasound transducer, the skin on the mother's abdomen formed blisters due to burns.No other clinical information or medical intervention was reported.
Additional Manufacturer Narrative
The information and picture(s) provided were reviewed by a philips product support engineer who provided the follow information.The transducer appears to be about one year old and looks as good as new, no discoloring of any kind visible.Anything that could theoretically produce heat is not under this double layer of yellow thermoplastic polyurethane (tpu) near the edge of the transducer, but behind the smooth gray plastic center of the transducer.The "crescent-shaped" burn-like blistering (seen in the provided picture) of the skin matches the shape of the tpu.In addition, the fetal monitor does not deliver enough electrical energy for a transducer to heat up that much and cause a burn injury.If the burn is caused by the transducer, the point of injury must be in the center, not at the edges.Also, the yellow polyurethane rim at the edges will deform/discolor due to heat.Clinical assessment was performed by a philips clinical expert based on available information.It was clarified by the customer that the transducer is wiped with a dry paper towel and not disinfected.Research & development reviewed the pictures of the burn and they match the outer polyurethane edge of the transducer, which would not produce heat for a burn due to no components being under it.It was thought the reported burn was likely chemical in nature; however, there was no confirmation of chemical use by the customer.It remains unknown the true cause of the reported issue or whether there was any intervention and if the burn healed completely.According to our findings and with all the facts, it remains unknown the true cause of the reported issue.We can conclude that this burn injury did not result from a thermal effect, but from a chemical irritation, most likely from residues from prior cleaning & disinfection.The customer was provided the warning statement from the instructions for use (ifu).The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: AVALON US TRANSDUCER
• Common Device Name: AVALON US TRANSDUCER
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 19815783
• Report Number: 9610816-2024-00448
• Device Sequence Number: 8684382
• Product Code: HGM
• UDI-Device Identifier: 00884838002722
• UDI-Public: (01)00884838002722
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K140535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: M2736A
• Device Catalogue Number: M2736A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female