MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3150 UPGRADE REL N.01; CENTRAL STATION MONITOR

Model Number M3150

Device Problems No Audible Alarm (1019); Device Inoperable (1663)

Patient Problem Death (1802)

Event Date 01/27/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that they did not hear the spo2 no sensor alarm at the central station or receive a page for the inop, and a patient expired.

Manufacturer Narrative

No device malfunction occurred.Per communications with the fse, a cas visited the customer site, and it was determined that there was no issue with the central station.It was indicated that the alarm was issued on the central station, but the ward staff were busy and did not notice the alarm on the central station.This is considered a user alarm handling issue.

• Brand Name: M3150 UPGRADE REL N.01
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7348444
• MDR Text Key: 102730098
• Report Number: 1218950-2018-02647
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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: 68 YR