MAUDE Adverse Event Report: VYAIRE MEDICAL 3100B VENTILATOR; VENTILATOR, HIGH FREQUENCY

Model Number 3100B

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect device/component will be reworked.The device is not available for analysis and no return good authorization (rga) has been issued or requested by the customer for the device.At this time, vyaire medical has not received the suspect/component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported this ventilator device power cycled off (shut down), while in patient use.The customer stated the device was cycled on however, the on/off power switch appeared compromised and the device cycled off.The patient was placed on an alternate device and no patient harm or injury was associated with this event.

Manufacturer Narrative

Device evaluation: g4, g7, h2, h3, h6 and h10 result of investigation: the customer sent the technical problem report and reviewed by vyaire technical support.It was seen that the electrical current of the unit is at 2.8 ampere.During the test run, customer found the defective unit has switched off a few times.The occurrences appear differently, the device power switched off after power-on for 3 hours, 8 hours and sometimes more.The customer replaced the power switch and test run again.The device still has the same problem.During overheat test, when the customer increased the amplitude, the driver stopped working.It was determined that the power supply assembly needs to be replaced.

• Brand Name: 3100B VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9304841
• MDR Text Key: 166738872
• Report Number: 2021710-2019-11012
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003512
• UDI-Public: (01)10846446003512(11)20180912
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100B
• Device Catalogue Number: 771453
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention