MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP2

Model Number	865040
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Codes	Unspecified Respiratory Problem (4464); Insufficient Information (4580)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted after philips obtains more information concerning this event.Reporter phone #: (b)(6).Reporting address state: (b)(6).
Event or Problem Description
The customer reported that the system did not alert, resulting in a need to reanimate the patient.
Additional Manufacturer Narrative
Results of functional testing indicate no malfunction on the mp2 device.The specified problem could not be reproduced.No other problems were found during testing.Device is fully functional.The bedside ivpm bedside xmon14 alarm review photos provided by field prove that there have been alerts, including red alerts @10:18, @10:22 and @10:24, for the bed during time frame of 10:12 to 10:29.For nibp measurement there couldn¿t be an alert for the time of ~ 10:20 since the last nibp measurement was done @09:28.Nibp measurement was likely set to manual by user, instead of automatic (default).For spo2 measurement the spo2 sensor was detached @10:17 from the finger.This was a technical inop announced as cyan alarm, but as there were other higher alarms raised (red ecg vent fib/tachy) only the red alarms were announced.Since the spo2 sensor was detached, there cannot be any other alarms afterwards anymore for spo2.There have been several ecg red alerts for the time frame alleged.The monitor seem to be disconnected from central for ~35 seconds, which means for that for the alleged time frame no alerts of bedside ivpm xmon14 given at picix.Nevertheless the ivpm bedside xmon14 alerted this condition to user by an inop ¿no central¿ and this alert was silenced at the ivpm bedside xmon14 by the user according to the picix audit log.Which can lead to the conclusion that a clinical user was operating the ivpm bedside xmon14.Based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction on the device.The reported problem was not confirmed.

• Brand Name: INTELLIVUE MP2
• Common Device Name: INTELLIVUE MP2
• 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: 16310840
• Report Number: 9610816-2023-00063
• Device Sequence Number: 17843312
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150310
• 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
• Initial Reporter Occupation: Other Health Care Professional
• 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: 865040
• Device Catalogue Number: 865040
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2014
• 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: Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 100 KG