MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE SMART-HOPPING APC

Model Number	865346
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the biomedical engineer, and checks of the apc's indicates by then everything was back online.The biomedical engineer confirmed that the system was real-time waveform streaming and alarming as designed.The rse sent the apc install guide at case level.The biomedical engineer requested led interpretation.The rse referenced pages in the email.The biomedical engineer requested the case could be closed.A good faith effort (gfe) was made to obtain additional information on the reported issue., no further response was received.The biomedical engineer did not provide root cause.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device due to insufficient information because the customer did not provide the root cause for the issue.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
The customer reported a "telemetry was not communicating because of access point system".The device was in clinical use at the time of the event.No adverse event or patient harm was reported.

• Brand Name: INTELLIVUE SMART-HOPPING APC
• Common Device Name: INTELLIVUE SMART-HOPPING APC
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19701850
• Report Number: 1218950-2024-00494
• Device Sequence Number: 7719991
• Product Code: MHX
• UDI-Device Identifier: 00884838009875
• UDI-Public: (01)00884838009875
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

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: 865346
• Device Catalogue Number: 865346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2017
• 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
• Patient Sex: Unknown