MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, NON-CONTINUOUS

Model Number INFANT FLOW SIPAP

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the suspect valve sensor printed circuit board component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect valve sensor printed circuit board 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 an intermittent loss of pressure and an e33 error on this device during patient use.The customer stated no patient harm or injury was associated with this event.The customer evaluated the device and determined the likely cause of this failure was the valve sensor pcb and a replacement was ordered.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8850163
• MDR Text Key: 152912523
• Report Number: 2021710-2019-10596
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446063554
• UDI-Public: (01)10846446063554(11)20181227
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INFANT FLOW SIPAP
• Device Catalogue Number: 27444-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention