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

Model Number VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

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 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
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion85; parque undustrial mexicali iii; mexicali, 21397 ; MX 21397
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9771963
• MDR Text Key: 206393395
• Report Number: 8030673-2020-00083
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752123014
• UDI-Public: (01)10190752123014(10)2022-04-30
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1