MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ INFANT FACE MASK SIZE 2; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	MASK, ANES, FLEX, INF SIZE 2, TOP VLV
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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 that 6820 mask, anes, flex, inf size 2, top vlv would not stay inflated.After a caesarian-section in the operating room, the baby needed cpap (continuous positive airway pressure).The face mask would inflate with a syringe but defalte with use.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: based on the investigation and since customer did not send pictures or physical sample of the fg part number 6820 with lot number 0004229563 for the investigation.We require the physical sample and/or pictures as evidence to perform a better investigation and determine the cause of the reported defect.In addition, the device history record of the fg part number 6820 with lot number 0004229563 was reviewed and no issues related with the reported defect were found.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS¿ INFANT FACE MASK SIZE 2
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): SHENZHEN VITAL SIGNS-KTL MEDICAL INSTRUMENT CO LTD; building 3, no.88 north jiaoyu; road, gaoqiao industrial park; shenzhen guangdong 51811 7; CH 518117
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18432138
• Report Number: 3013421741-2024-00055
• Device Sequence Number: 7867424
• Product Code: CAI
• UDI-Device Identifier: 10190752147416
• UDI-Public: (01)10190752147416(10)0004229563
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 01/02/2024

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: MASK, ANES, FLEX, INF SIZE 2, TOP VLV
• Device Catalogue Number: 6820
• Device Lot Number: 0004229563
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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