MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP30 INTELLIVUE PATIENT MONITOR; COMPACT PATIENT MONITOR

Model Number M8002A

Device Problem No Audible Alarm (1019)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Date 10/12/2019

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the intellivue mp30 patient monitor failed to alarm for low spo2 on (b)(6) 2019 between 04:00 a.M.And 06:30 a.M.The patient was found unresponsive and in asystole, and resuscitation was attempted, but was not successful.The patient died.

Manufacturer Narrative

H3 and h6: the monitor and all accessories were tested by the onsite biomed and found to be working as intended.All alarms were generated as expected and no trouble was found with the device.Additionally, a hugo technologies field service engineer (fse) went onsite and collected the audit log which was forwarded to philips product support engineering (pse) for further analysis.During the evaluation of the provided log, pse found that the general audit log "neuropiicix_auditlog.Zip" did not contain any data for the reported date of event (b)(6) 2019, but started with (b)(6) 2020.The filtered audit log "audit logs.Csv" showed multiple entries for the bed label west4 for the reported date and time frame.It was found that a patient was discharged at 03:59 and multiple settings were changed in the monitor configuration after the discharge.There are no entries in the log for the time frame of 04:44 until 06:15 which could indicate that the patient was most likely not admitted to the monitor.Additional data for this time frame, such as the alarm review from the monitor or a print-out of trend / event data was not available and an analysis was not possible.Based on the analysis of the provided logs, no indication of a monitor malfunction was found for the time of 06:15 onward, however, no analysis was possible for the time frame of 04:44 until 06:15.The customer was advised of the investigation outcome by letter.Although multiple spo2 low and desaturation alarms were generated and silenced or paused from 06:15 onwards, no data was entered in the log for the time of 04:44 until 06:15.Due to the lack of available data for this period of time, such as alarm review and trend / event data, an investigation for this time was not possible and a malfunction of the monitor cannot completely be ruled out.No subsequent calls were received from the customer regarding the reported device and issue.The available information from this report does not support that this failure represents a systemic, design, or labeling problem.No further investigation or action is warranted.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MP30 INTELLIVUE PATIENT MONITOR
• Type of Device: COMPACT PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9254828
• MDR Text Key: 164257356
• Report Number: 9610816-2019-00288
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K030038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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: M8002A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death