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

Model Number	27416-001
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other ¿ the suspect device has not been returned for evaluation.However, vyaire medical's technical support team was able to resolve the customer's issue by assisting the customer by troubleshooting and ordering a replacement device.D4: unique identifier (udi) # -unable to determine entire udi number, as manufacturing information was not provided.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical: no alarm sounding, battery is currently measured at 10.35v and the display is blank.We are unable to see if there is an e20 or 21 error code, since the display is blank.No patient involvement.

• Brand Name: INFANT FLOW SIPAP
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19960892
• Report Number: 3013421741-2024-00328
• Device Sequence Number: 20599062
• Product Code: CBK
• UDI-Device Identifier: 10190752158627
• UDI-Public: (01)10190752158627
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27416-001
• Device Catalogue Number: 27416-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown