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

Model Number	VITAL SIGNS® PRESSURE INFUSOR
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The customer reported that the vital signs® pressure infusor has a leaking valve.It happened during use, and the machine alarmed "o2 calibration" and "occlusion." the patient had to be sedated further in order to stop the alarm from sounding.Harm or injury is unknown.
Additional Manufacturer Narrative
The device history record review show all units were proceeded leakage test according to work instruction and the inspection record showed the sampling inspection of manufactured lot pass all the inspection requirement on visual and packaging requirement.The mwi-51004353-as-004/a showed the assembly method was welding the pvc tube with flange with using the rf welding machine.In mwi-510043xx-as-004 rev.:b.,which effective on (b)(6) 2016, cyc was applied for bonding of tube flange and 8 inch pvc tube instead of using welding method , due to the material incompatibility contributes to the root cause of the non weld.Due to the lack of material for evaluation and application information, the actual failure analysis could not be performed.The cause of reported case is currently undetermined.

• Brand Name: VITAL SIGNS® PRESSURE INFUSOR
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• MDR Report Key: 11426662
• Report Number: 3004050971-2021-00015
• Device Sequence Number: 11772325
• Product Code: KZD
• UDI-Device Identifier: 10817357021063
• UDI-Public: (01)10817357021063(10)160193
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention