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

Model Number M8007A

Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/24/2014

Event Type  Injury  

Manufacturer Narrative

A philips field service engineer has been on site and has evaluated the device, as well as alarm logs.This investigation shows that the device worked as expected, and the issue could not be reproduced.Photographs of the alarm history have been provided for the reported timeframe which clearly show multiple alarms for this patient (extreme brady 58 bpm or heart rate low).The logs also show that the device provided several blue technical alarms (inops) to alert the staff that the ecg leads, and spo2 sensor were off at 10:30 am.The alarms were also turned off several times and then back on again (10:46 ¿ 10:47), and there was an asystole at 11:04 am.When a spo2 sensor has fallen off a patient, the device cannot measure the parameter, and therefore cannot provide alarms for a desaturation event, but would provide an inop ¿spo2 sensor off¿, as in this case.The issue has been resolved by instructing the user about alarms behaviour.This is all that was necessary to fully resolve the issue.The device remains at the customer site.This investigation determined there was no device malfunction.

Event Description

The customer reported that "users didn't notice the desaturation of a patient, which was being monitored on a mp70 + central station.They claim the monitor did not alarm." this case was logged as a serious injury but there are no details available as for which injury it was.It was reported that there was a delay in therapy.No further information is available.

• 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: nancy ataide ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 6328986
• MDR Text Key: 67371550
• Report Number: 9610816-2017-00043
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/19/2014

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: 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
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2009
• 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