MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problem No Audible Alarm (1019)

Patient Problem Hypoxia (1918)

Event Date 08/18/2023

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the intellivue mx800 patient monitor did not audibly alarm for a desaturation event for the patient in room c23 on (b)(6) 2023 between 14:00 and 14:30.The device was in use monitoring a patient at the time of the reported event.The patient needed to be resuscitated.

Event Description

The customer reported that the intellivue mx800 patient monitor did not audibly alarm for a desaturation event for the patient in room c23 on (b)(6) 2023 between 14:00 and 14:30.The device was in use monitoring a patient at the time of the reported event.The patient later passed away.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the device and confirmed with the customer that the alarms were silenced during the times in question.It was confirmed that the patient was a 32-year-old male.The complaint was escalated for technical investigation by a philips product support engineer (pse) for the allegation that "last friday (b)(6) 2023 between 14:00 and 14:30 in room c23 of micu at (b)(6) hospital a patient coded, and the nurse felt like a desaturation (desat alarm) wasn't making audible noise in room at monitor during resuscitation of patient." the pse evaluated the device logs provided by the customer and saw several alarms being announced at the central station.These alarms were coming from the bedside labeled c23 and there was no indication that there was no alarm.The pse confirmed there were desat alarms during the mentioned timeframe and stated, ¿from what i see, the monitor worked and alarmed as expected".Based on the information available and the testing conducted by the fse, log analysis from our pse and cas, it has been concluded that ¿the monitor worked and alarmed as expected¿ and the device did not cause or contribute to the patient¿s death.It is evident from the aforementioned investigations that the monitor was silenced in the room during the times in question.The engineer provided their analysis findings.The device was confirmed to be operating per specifications, no failure was identified and the device did not cause or contribute to the patient¿s death.It is evident from the aforementioned investigations that the monitor was silenced in the room during the times in question.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

It was stated that the patient has died.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• 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 ; 7031463203
• MDR Report Key: 17681096
• MDR Text Key: 322603132
• Report Number: 9610816-2023-00441
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,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
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/05/2023; 10/05/2023
• Supplement Dates FDA Received: 09/08/2023; 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 32 YR
• Patient Sex: Male