MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS TELEMETRY SYSTEM TRANSMITTER

Model Number M2601A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital biomed reported "someone had turned off the alarms to the mx40 on (b)(6) 2020 from 1:00 am to 3:00 am." the patient coded then expired but the monitor did not alarm.

Manufacturer Narrative

H10:a philips field service engineer (fse) provided the alarm audit log to include patient management (ptmgt) log from the hospital site.Our philips product support engineer (pse) reviewed the logs provided.The pse found that the alarm audit log data was from (b)(6) 2020 and contained no data from (b)(6) 2020, which is the date of the incident referenced above.The ptmgt log contains information associated with the patient¿s admit/discharge actions and patient demographic changes; it does not contain any alarm-related information.Based on our investigation, philips has insufficient information to make a determination on how the telemetry transmitter alarmed as the alarm logs for the date and time of the incident were not available for review.This information was provided to the customer.The device remains at the customer site.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: TELEMETRY SYSTEM TRANSMITTER
• Type of Device: TELEMETRY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11098492
• MDR Text Key: 225327558
• Report Number: 1218950-2020-08163
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K961165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M2601A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR