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

Model Number 865240

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2024

Event Type  Death  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.Reporter phone number (b)(6).

Event Description

The customer reported that the monitor did not alarm correctly and a patient passed away.The device was in clinical use.

Event Description

Philips received a complaint on the intellivue mx800 patient monitor indicating that the monitor did not alarm correctly, the patient's condition worsened, and they passed away.A good faith effort (gfe) was performed to ask the official cause of death or what alarm was expected by the user that did not alarm correctly, but no additional information was provided.The device was in use at the time.

Manufacturer Narrative

The customer was contacted multiple times to get more details and was escalated to several recommended stakeholders in the management department of the hospital, but no additional details were provided.The complaint was escalated for technical investigation, and a clinical product specialist reviewed the clinical audit log and data provided.The clinical audit log shows a timeframe of about 9 minutes from 23:59 on (b)(6) to 00:08 on (b)(6).The bed in question appears to be 403-2.The patient was being monitored for hr, spo2, art and temperature at a minimum.Throughout this timeframe, there were repeated inops for "temp no sensor".00:00:56 spo2 88<90 yellow alarm is generated.00:01:35 desat 80<85 red alarm is generated (escalation of low spo2 alarm).00:01:40 ves/min 11>10 is generated.00:01:53 silence of alarms at ix-int2 4 times in 1 second.00:03:56 artm 54<60.00:04:36 silence at ix-int2 3 times.00:05:41 43 desat 1<86 ends when spo2 no pulse is generated (supports that desat alarm was active for approx.4 minutes until no pulse inop occurred).Temp and spo2 inops continue.00:07:40 artm 22<60 ends.00:07:41 hr 53<55 generated.00:07:54 artm 35<60 generated.00:08:00 pause all alarms.Based on the information available, the audit log shows the monitor was providing alarms, including the low spo2, temp no sensor inop, pvc/min high, and low mean art pressure.The low mean art pressure was a red alarm.The spo2 value and the mean art pressure values continued to drop.Then, a low hr alarm was generated.The low hr alarm is a short yellow alarm, so the alarm would have played for 6 seconds and then stopped.However, the numeric would have continued to flash, and the pic ix sector would have remained blue for 3 minutes if it was not acknowledged.There was no evidence in the audit logs that the monitor did not alarm.After multiple attempts to obtain further details regarding this incident, the customer did not provide any specific data, configuration file, or strips, and without this information, we are not able to draw any definite conclusions or determine a likely cause.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.We are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 18866498
• MDR Text Key: 337226701
• Report Number: 9610816-2024-00139
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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
• 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: 02/10/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2012
• 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): Death