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	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the vital signs® pressure infusor experienced defective pressure bag.It will not hold air when inflated.As of this time, there is no information regarding patient harm with this reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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: 11988202
• Report Number: 3004050971-2021-00020
• Device Sequence Number: 3362887
• Product Code: KZD
• UDI-Device Identifier: 10817357021308
• UDI-Public: (01)10817357021308
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

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: VITAL SIGNS® PRESSURE INFUSOR
• Device Catalogue Number: IN800012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 73