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

Model Number M8007A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 05/10/2018

Event Type  Death  

Manufacturer Narrative

(b)(6).A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that "on a mp70 rev k.21 monitor, the users declare that the heart rate (hr) may have not been correctly calculated because of a low amplitude ecg signal.When the ecg size has been changed, the hr changed also.Rcp has been provided to the child, where it may not have been necessary".The patient died.

Manufacturer Narrative

The intellivue mp70 patient monitor was used to monitor the pediatric patient in bed 3 on (b)(6) 2018 around 17:10, when an incorrectly calculated heart rate (hr) resulted in the clinical staff providing cardio-pulmonary resuscitation (cpr) that may not have been necessary.The ecg amplitude during this event was low, even after an exchange of the ecg lead set.The customer was using philips-approved ecg lead sets and non-philips ecg electrodes.A philips application specialist (as) provided the audit log file, the screen capture from the trend review, as well as print-outs from the event/trend review which were forwarded to philips product support engineering (pse) for evaluation.During the evaluation of the screen shots/recordings, pse found that the minimum detection threshold for the ecg algorithm was not met.The ecg amplitude was around the detection threshold of 150 ¿v.Based on internal filtering, the st/ar arrhythmia algorithm might have received an even smaller amplitude which then resulted in a false asystole alarm with a hr of 0 and the ensuing cpr.It is therefore recommended to select a lead with a minimum amplitude of 0.5 mv.The configured patient profile (adult, pediatric, neo) does not impact the hr calculation.The qrs detection always uses the gain x1 signal, and the gain factor only affects the ecg wave shown on the monitor display.Additionally, the as advised the customer that the pulse measured with spo2 was available during the time frame of the inaccurate hr and that the ecg lead selected did not show enough amplitude to be considered for the hr calculation.The customer was advised about the detection threshold requirements and the philips st/ar arrhythmia application note was sent to the customer for further reference.The product remains in use at the customer site.The device worked as intended and there was no malfunction of the monitor.The customer did not allege the monitor to be a factor in the reported death.This issue was caused by a user misunderstanding of the ecg algorithm functionality.No further investigation or action is warranted.

• 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: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7534184
• MDR Text Key: 108918023
• Report Number: 9610816-2018-00126
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/14/2018

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: 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: 05/14/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/14/2018
• Supplement Dates FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2008
• 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: 15 MO
• Patient Weight: 8