MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. SENSORMEDICS 3100A; VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problems No Audible Alarm (1019); Disconnection (1171)

Patient Problem No Information (3190)

Event Date 06/08/2018

Event Type  malfunction  

Event Description

The map alarm was not audibly working.The map drifted, alarm light came on, but no audible alarm heard.Alarms set appropriately, but ventilator did not sound when alarms reached.Manufacturer response for ventilator, sensormedics 3100a (per site reporter).Unit under a service contract.Called for service.Biomed told to look inside for speaker wire disconnect.Wire was off.Reconnected the wire, plugged unit in then removed ac power.Got an audible power fail alarm which shows speaker now working.Unit returned to service.

• Brand Name: SENSORMEDICS 3100A
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 7628965
• MDR Text Key: 112013962
• Report Number: 7628965
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Other Device ID Number: 08212/1152834
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO