MAUDE Adverse Event Report: VYAIRE MEDICAL. VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical performed a failure investigation and determined that the personnel could be related to the reported defect due to they are not certified to perform the inspection of the product at packaging area due to inspection is a critical operation.It was determined the root-cause was traced to personnel and capa has been initiated under capa-(b)(4).Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the vital signs® adult anesthesia breathing circuit is leaking while connected however the customer confirmed that no patient harm was associated on this event.

• Brand Name: VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9771963
• Report Number: 8030673-2020-00083
• Device Sequence Number: 14190926
• Product Code: OFP
• UDI-Device Identifier: 10190752123014
• UDI-Public: (01)10190752123014(10)2022-04-30
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

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® ADULT ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AMY520X4F
• Device Lot Number: 2022-04-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1