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

Model Number	VITAL SIGNS® PRESSURE INFUSOR
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not available for return, as it may have already been discarded at this point.No further evaluation can be completed at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the vital signs pressure infusor is unable to maintain pump level.The issue occurred during patient-use and the device was replaced with another pressure infusor.The customer confirmed that there was no patient harm associated with the reported event.

• 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
• MDR Report Key: 10901167
• Report Number: 3004050971-2020-00011
• Device Sequence Number: 2709263
• Product Code: KZD
• UDI-Device Identifier: 10817357021063
• UDI-Public: (01)10817357021063(10)192980
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS® PRESSURE INFUSOR
• Device Catalogue Number: IN800048
• Device Lot Number: 192980
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention