MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS® PRESSURE INFUSOR; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).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.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the infusor, pressure, 500 ml, netted, 12/cs bag is unable to pressurize.Patient involvement is not confirmed at this time.
Additional Manufacturer Narrative
H11: after further review of this complaint, vyaire medical found out that this complaint only had an accessory defect and no patient was involved.Therefore, this is deemed as a non reportable complaint to vyaire medical.Please disregard and void vyaire reference number: (b)(4) under mfr report number: 3013421741-2023-00036.

• Brand Name: VITAL SIGNS® PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district, tangxia; dongguan 52373 0; CH 523730
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 17284078
• Report Number: 3013421741-2023-00036
• Device Sequence Number: 2985475
• Product Code: KZD
• UDI-Device Identifier: 10190752133723
• UDI-Public: (01)10190752133723(10)223787
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2023

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: INFUSOR, PRESSURE, 500 ML, NETTED, 12/CS
• Device Catalogue Number: IN800012
• Device Lot Number: 223787
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 07/09/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown