MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 09/13/2014

Event Type  Death  

Manufacturer Narrative

There was no device malfunction.A review of the logs also showed that multiple red level alarms occurred between 07:07 am and 07:24 am, which were silenced or suspended (paused) by users.At 7:24 am, users had turned off all arrhythmia/ecg alarms at the bedside monitor before the patient asystole event.Philips confirmed that the device did not alarm for asystole due to all ecg alarms having been turned off before the event occurred.The product labeling describes that when alarms are disabled in this way a bell with an "x" is displayed next to the heart rate numeric and the visual message "all arrhy alarms off" is displayed on both the bedside monitor and the information center.No further investigation or action is warranted.

Event Description

It was reported that on the (b)(6), between 7:00 am and 9:00am, a patient went into asystole.Because the alarms were off, the event was missed, leading to a delay in performing defibrillation.The patient died after the event.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 5611977
• MDR Text Key: 43789102
• Report Number: 9610816-2016-00117
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/15/2014

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?: No
• Device Operator: Other Health Care Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2004
• 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: 62 YR