MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AV-US ULTRASOUND XDR USA NROHS

Model Number	453564207971
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the transducer shocked the patient.The device was in use at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) remotely interviewed the nurse lead (nl) who was onsite and helped with the troubleshooting after the issue occurred.The nl indicated one of the other nurse staff (ns) administered the nonstress test (nst) on the patient who was pregnant with twins.The two ultrasound transducers were in use when after a minute the patient asked the nl if there should be a buzzing or tingling sensation during the nst.She pointed to the ¿bad¿ transducer and the nl removed it immediately.The nl put the bad transducer on her own palm, and also felt what the patient was describing.The nl described the feeling to be more like a constant prickling feel and it wasn¿t overtly painful.The patient was not harmed and required no treatment.The nl reported they continued the patient¿s nst on a different monitor and attempted to troubleshoot the problem.They unplugged the transducer from the fetal monitor and tried it in a different port.We could not replicate the sensation.They also tried plugging it back into the initial port, and it felt fine.The transducer had recently been received back from repair with a slight crack on the case.They sent the cracked transducer back for repair.The nl and staff wondered if perhaps the transducer was not plugged all the way into the port, and that caused the problem.The fetal monitor itself seems to be working fine.The customer replaced the faulty ultrasound transducer with a new one to resolve the issue.The customer sent the faulty ultrasound transducer to the bench for further evaluation and the bench repair technician (brt) confirmed the device to have crystal defects caused by decreasing bond of the piezo crystals due to aging process.The faulty part was later scrapped.

• Brand Name: AV-US ULTRASOUND XDR USA NROHS
• Common Device Name: AV-US ULTRASOUND XDR USA NROHS
• 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: 17343009
• Report Number: 9610816-2023-00364
• Device Sequence Number: 20561157
• Product Code: MHK
• UDI-Device Identifier: 00884838021488
• UDI-Public: 00884838021488
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K110622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 453564207971
• Device Catalogue Number: 453564207971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2011
• 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
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 80 KG