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 11/30/2016

Event Type  Death  

Manufacturer Narrative

A philips solutions center (sc), clinical specialist (sc) assisted the customer remotely.The nurse stated that the spo2 parameter alarm was turned off at the time of the incident.Data logs were collected and analyzed confirming that the mp70 monitor's spo2 parameter alarming was turned off on (b)(6) 2016, therefore no spo2 alarming could occur.Once the nurse turned the spo2 monitoring on, at 19:08 on (b)(6) 2016 she immediately saw a desat 58 < 85 generated at 19:08:06, indicating that the monitor was alarming as configured.Trend data provided shows that the spo2 measurement was on, as values were populated in the trend review during this timeframe although the measurement for spo2 alarming was off.When switching individual measurement alarms on or off the alarms off symbol is shown beside the measurement numeric, indicated as a triangle with an x through it to alert the user.No malfunction of the mp70 intellivue monitor occurred.The information about the log data has been provided to the customer from the solutions center (sc).The device remains at the customer site.

Event Description

The customer reported that on (b)(6) 2016 the patient¿s spo2 dropped to 58% but the monitor did not announce a spo2 desat alarm.No treatment information was provided for the drop in saturation, but the information provided stated that the patient subsequently died on (b)(6) 2016.

• 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: robert corning ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6202773
• MDR Text Key: 63236087
• Report Number: 9610816-2016-00333
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health 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
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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