MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW SIPAP; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 677-002

Device Problem No Display/Image (1183)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Vyaire complaint number: (b)(4).The vyaire failure analysis lab was unable to replicate the reported problem.The issue was resolved by replacing the battery, ribbon cable and updated software.The sipap unit was tested per service manual and meets factory service specifications.

Event Description

Vyaire medical received a customer report of a device where the screen on the sipap is white and in alarm.The led remains red.Patient involvement is unknown at this time.

• Brand Name: INFANT FLOW SIPAP
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11356627
• MDR Text Key: 233059680
• Report Number: 2021710-2021-13443
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10846446005387
• UDI-Public: (01)10846446005387
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 677-002
• Device Catalogue Number: 27476-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1