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	Cardiac Arrest (1762)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported the patient's spo2 reading displayed as low as 40% but no alarm was generated.The patient went into cardiac arrest and was transferred to the icu.After reviewing the clinical audit log, it was determined the spo2 alarms were turned off by the end user.The patient was also being monitored by central telemetry, where the spo2 alarms were turned off at the pic ix.The device was in use on a patient.There was a report of patient or user harm.
Event or Problem Description
It was reported the patient's spo2 reading displayed as low as 40% but no alarm was generated.The patient went into cardiac arrest and was transferred to the icu.After reviewing the clinical audit log, it was determined the spo2 alarms were turned off by the end user.The device was in use on a patient.There was a report of patient or user harm.
Additional Manufacturer Narrative
Philips product support engineering (pse) reviewed provided audit logs from the pic ix.Per pse, the event began (b)(6) 2024 at 05:40am.That timestamp falls between the time where the user turned off the spo2 alarms at 11:29:36am on (b)(6) 2024 and then turned spo2 alarms back on at 7:03:08am on (b)(6) 2024, as seen in the audit log.Further relevant information was requested and it turned out that the alarms were turned off by the end user on the central station and on the monitor as well.Based on the information available and the review of the audit logs, the cause of the reported problem was the users turning off the spo2 alarms.The reported problem of an alarm failure was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.

• 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: 20062485
• Report Number: 9610816-2024-00549
• Device Sequence Number: 18252828
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: (01)00884838082595
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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?: 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: 07/30/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2019
• 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: Required Intervention
• Patient Sex: Unknown