MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 INFO CNTR LOCAL DB REL N.01; CENTRAL STATION MONITOR

Model Number M3150

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that the central station failed to alarm on (b)(6) 2021 or (b)(6) and a patient experienced a ventricular fibrillation (vfib) event.

Manufacturer Narrative

The initial report was submitted in error.This report is a duplicate of manufacturer's report number 1218950-2021-00848.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: M3150 INFO CNTR LOCAL DB REL N.01
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11301130
• MDR Text Key: 230962731
• Report Number: 1218950-2021-00849
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: M3150
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening