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

Model Number 865240

Device Problem Defective Alarm (1014)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 10/01/2023

Event Type  Death  

Event Description

Customer reported the apnea alarm failed.The device was in use on a patient.The patient passed away.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.Preliminary findings indicate the expected alarms were set to off by default, however, additional information is needed to determine cause.A final report will be submitted once the investigation is complete.

Event Description

The customer reported the intellivue mx800 patient monitor did not provide an apnea alarm.The device was in use on a patient.The patient passed away.

Manufacturer Narrative

A philips field service engineer (fse) visited the customer site to evaluate the alleged malfunctioning device, collect logs, and clinical audit trails.Functional tests performed and log review couldn¿t replicate the issue.Both x2 and mx-800 devices were working per specification.A philips product support engineer (pse) evaluated the clinical audit log and determined that the following alarms were on during the incident timeframe: ecg alarms, spo2 alarms, nbp alarms (from bedside device).Physiological alarms were provided for: vtach, vent fib/tach, **hr high limit violations, *pvc limit, *afib, *irregular hr.Technical inop alarms were provided for: ecg leads off, rl lead off, resp lead off, cannot analyze ecg, spo2 no sensor, spo2 sensor off, spo2 no pulse, nbp measurement failed.The customer initiated abp (arterial blood pressure) monitoring at 07:53:22 and abp alarms were turned on for the parameter." another pse reviewed the audit logs and stated "from the patient information center ix side, the system performed as expected ¿ frequent alarms for the beds/times in question, were sent to 3 pic¿s.The supplied alarm log shows frequent alarms being sent from the b355 to 3 different pic ix hosts (wkhix112/114/116) for the time period in question.Several of the alarms are for sp02 sensors off, a few for npb measurement failures.(b)(6) 2023 07:37:39 wellstar kennestone b355 acknowledge wkhix112 acknowledge.(b)(6) 2023 07:26:14 wellstar kennestone b355 acknowledge wkhix112 acknowledge.(b)(6) 2023 07:26:14 wellstar kennestone b355 acknowledge wkhix112 acknowledge.(b)(6) 2023 07:17:10 wellstar kennestone b355 acknowledge m355 acknowledge.(b)(6) 2023 07:05:30 wellstar kennestone b355 acknowledge m355 acknowledge.(b)(6) 2023 06:53:54 wellstar kennestone b355 acknowledge m355 acknowledge." a philips clinical specialist (cs) evaluated the clinical audit logs and configuration files, stating the following: "i do not see an apnea alarm in this case.There is a desat alarm at 4:38:20 that ended at 4:38:58.Previously, there were lots of spo2 low and desat alarms.After this, there are multiple spo2.No pulse and interference inops.They must have their alarms set to not latch since the alarms stop on their own without and acknowledgement of the alarm.There are also low nbp alarms during this time and the nbp measurement failed at 7:19:28.The vent fib/tach alarm was generated at 7:33:19." i see the following alarms in the audit log between 07 to 0730 on (b)(6) 2023: low nbp alarms, spo2 no sensor, sensor off, and no pulse inops, afib , nbp measurement failed inop the spo2 was having inops since (b)(6), 2023 at 14;22;56.Between 0700 and 0730, the spo2 was displaying inop alarms.Nbps 82<90 alarm was generated at 07:00:23.The nbp measurement failed inop was generated at 07:16:34, 17:19:52, and 7:332:37.Respiratory leads off was generated at 7:32:58.The configuration file revealed the respiratory alarms are off by default as shown below.The cs also confirmed that if the intellivue x2 is docked to the host monitor (mx800), alarming would occur at the host monitor.Main setup - measurements - resp: item= measmt.Adult measmt.Pedi measmt.Neo high limit= 40 rpm, 30 rpm, 100 rpm, 30 rpm.Low limit= 8 rpm, 8 rpm, 30 rpm, 8 rpm.Apnea time= 20 sec, 20 sec, 20 sec, 20 sec.Alarms= off, on, on, on.Resp= on, on, on, on.Based on the information available and the testing conducted, the cause of the reported problem was an user configuration issue, as respiratory alarms (includes apnea) were set to off by default.The reported problem was not confirmed.There was no malfunction of the intellivue mx800 patient monitor.The device was confirmed to have alarmed and worked per specifications.

• 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: 18265337
• MDR Text Key: 329671528
• Report Number: 9610816-2023-00641
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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
• Date Manufacturer Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2012
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 72 KG