MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX100

Model Number	867033
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/10/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted after philips obtains more information concerning this event.E1: reporting address state: (b)(6).
Event or Problem Description
It was reported while patient being monitored via ecg and sp02 the intellivue mx100 did not alarm while patient had low o2 readings.The patient died.
Additional Manufacturer Narrative
The field service engineer (fse) pulled the clinical audit logs, the patient information center ix (pic ix) logs, and device configuration and logs.The fse used simulators to generate both ecg and spo2 alarms on both the monitor and central station using biomedical surveillance.The monitor appeared to alarm as expected.The complaint was escalated for technical investigation and the results indicate that the equipment was functioning properly and that alarms should have been heard at the pic ix.The provided logs were reviewed by a business unit product support engineer (pse).The pse reviewed the audit log, and on september 9th at 04:21, spo2 was turned on, but at 04:59, the ¿sensor off¿ inop was generated and then ended a few seconds later.A ¿sensor off¿ inop means that the sensor is connected to the mx100 device, but not properly applied to the patient.Inops are technical alarms that indicate the monitor cannot measure or detect alarm conditions reliably.A ¿spo2 sensor off¿ inop interrupts monitoring and alarm generation.The measurement numeric is replaced with a ¿-?-¿, and the inop tone plays.There were multiple instances of the ¿sensor off¿ inop, meaning the connection of the sensor to the patient was not properly connected and the monitor was not able to generate alarms.At 04:59, there is indication of spo2 being low as shown in brown highlight below, which means that the alarm was generated at the pic ix.After the alarms sounded, there is an ¿acknowledge¿ from the bedside by the user.This acknowledges all active alarms by switching off audible alarm indicators and lamps; however, the visual alarm indicators remain while the alarm condition is active and are displayed at the monitor and the pic ix.The customer was concerned about the gap in clinical audit logs.The pse advised in the stardate logs, the 3s-mx14 device is shown as being associated to the patient and started monitoring at 04:21 before it was disassociated at around 05:31.A minute before at 04:19, there are shown to be network alerts from the access point (ap)/access point controllers (apcs), which could indicate an issue with the ap/apc itself, which could cause the wireless monitors to not respond properly until the patient is within a better coverage of the ap/apc range.If there is an issue with the apcs/aps, they have to be resolved first.After those have been resolved, the patient must be within network coverage.The cause of the gap in clinical audit logs could be either the apcs/aps and/or the network coverage of the patient.The device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.Information is provided to the customer to resolve the issue.

• Brand Name: INTELLIVUE MX100
• Common Device Name: INTELLIVUE MX100
• 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: 17921318
• Report Number: 9610816-2023-00522
• Device Sequence Number: 2983181
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: 00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171801
• 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: Biomedical Engineer
• Type of Report: Initial,Followup

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: 867033
• Device Catalogue Number: 867033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• 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: Death
• Patient Sex: Unknown