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

Model Number M1205A

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that an alarm for vtach was not generated at the m1205a bedside monitor.Patient related involvement is captured and investigated in a separate complaint record.This current complaint contains the investigation of the alleged failure of the bedside device to provide an alarm for vtach.The device was in use monitoring the patient.

• Brand Name: V24/26 COMPONENT MONITORING SYSTEM
• Type of Device: BEDSIDE MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7369543
• MDR Text Key: 103690147
• Report Number: 9610816-2018-00081
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• PMA/PMN Number: K002758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1205A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1