MAUDE Adverse Event Report: MASIMO SWEDEN AB; GAS-MACHINE, ANESTHESIA

Model Number TOUCHSMART 9100

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  malfunction  

Event Description

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.

• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MASIMO SWEDEN AB; 52 discovery; irvine CA 92618
• MDR Report Key: 15275343
• MDR Text Key: 298407233
• Report Number: 15275343
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022,07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOUCHSMART 9100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2022
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1