MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS¿; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number B1714XXX

Device Problems Crack (1135); Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

Our vital signs¿ pediatric anethesia breathing circuit are not passing the leak tests on our machines due to holes cracks in the circuit hose.This is a new lot number with the same issue reported in a previous medical device report.Six were identified with this issue before all inventory of this lot # was set aside.Product also quarantined at user facility's fulfillment center.Manufacturer response for circuit, breathing (w connector, adaptor, y piece), vital signs¿ (per site reporter).Vyaire is currently investigating the issue.Credit was issued for the original issue, and they are sending a return label for us to send the devices for analysis.We have samples of all three lot numbers reported.

• Brand Name: VITAL SIGNS¿
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 510 technology dr.; irvine CA 92618
• MDR Report Key: 16520957
• MDR Text Key: 311053662
• Report Number: 16520957
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: B1714XXX
• Device Catalogue Number: B1714XXX
• Device Lot Number: 0004226339
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1