FDA Adverse Event Malfunction Summary report: N

GAS-MACHINE, ANESTHESIA

MDR report key: 15275343 · Received August 23, 2022

Report

Report Number
15275343
Event Type
Malfunction
Date Received
August 23, 2022
Date of Event
July 21, 2020
Report Date
July 29, 2022
Manufacturer
MASIMO SWEDEN AB
Product Code
BSZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
DC
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

A WORKSTATION HAD NOT BEEN ALARMING FOR FEW DAYS, BUT BIOMED GOT CALL. CHECKED THE PSN WORKSTATION AND SET UP SPO2 TEST AND WE SET ON EMPTY ROOM AND VERIFIED THAT NOT SOUND WAS COMING FROM THE PSN. TRIED RESETTING THE PSN BUT STILL NO SOUND, THEN NOTICED THAT THERE WAS HEADPHONES PLUGGED IN THE WORKSTATION AND THAT WAS NOT LETTING THE SOUND COME OUT, WE SHOWED DEPARTMENT MANAGER AND EXPLAINED IT TO HER, ONCE THE HEADPHONES WERE REMOVED FROM PSN WORKSTATION STARTED WORKING AS IT SHOULD. THIS INFORMATION WAS ALSO PROVIDED OR REPORTED TO MASIMO (B)(6) AND EXPLAINED TO ORIGINAL MANUFACTURER THAT THE PROBLEM WE HAD FOUND, AND MASIMO TECH SUPPORT PERSON SAID THAT THERE NOTHING THAT CAN BE DONE ON THEIR PART TO STOP THIS FROM HAPPENING AND THEY HAD GOTTEN CALL LIKE THIS INCIDENT BEFORE FROM DIFFERENT HEALTHCARE SYSTEM BUT NOTHING THEY CAN DO TO IMPROVE THE ISSUE OR NOTHING IN THE SYSTEM TO STOP ANYONE PLUGGING IN A HEADPHONE SPEAKER TO SINCE THE ALARM NIGHT TIME OR TO DISABLE ALARM BY PLUGGING HEADPHONE SPEAKER INTO WORKSTATION. MANUFACTURER RESPONSE FOR WORK STATION-COMPUTER, (BRAND NOT PROVIDED) (PER SITE REPORTER). MASIMO TECH SUPPORT PERSON SAID THAT THERE IS NOTHING THAT CAN BE DONE ON THEIR PART TO STOP THIS FROM HAPPENING AND THEY HAD GOTTEN CALL LIKE THIS INCIDENT BEFORE FROM DIFFERENT HEALTHCARE SYSTEM BUT NOTHING THEY CAN DO TO IMPROVE THE ISSUE OR NOTHING IN THE SYSTEM TO STOP ANYONE PLUGGING IN A HEADPHONE SPEAKER TO SINCE THE ALARM NIGHT TIME OR TO DISABLE ALARM BY PLUGGING HEADPHONE SPEAKER INTO WORKSTATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2595922 GAS-MACHINE, ANESTHESIA BSZ MASIMO SWEDEN AB TOUCHSMART 9100

Patients

Seq Age Sex Outcome Treatment
1 Unknown