MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS V24/26 COMPONENT MONITORING SYSTEM; BEDSIDE MONITOR

Model Number M1205A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/07/2014

Event Type  Death  

Manufacturer Narrative

Following a conversation with the fse, it was proven that the device did not malfunction and according to the fse, the device did not contribute to the patient death.The device was tested and showed to have worked as expected.This issue does not pose any additional health risks to the patient.The device did not malfunction and is in clinical use after testing which showed that there was malfunction.

Event Description

The customer has stated that the device was showing a heart rate of 50 although the patient was in asystole.This is being reported as a patient death.According to the philips fse the device did not contribute to the patient death.No further information is available.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Type of Device: BEDSIDE MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6329022
• MDR Text Key: 67369849
• Report Number: 1218950-2017-00972
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1205A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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