MAUDE Adverse Event Report: VYAIRE MEDICAL. CIRCUIT 3100A 38IN F&P 850 4/CS; VENTILATOR, HIGH FREQUENCY

Model Number CIRCUIT 3100A 38IN F&P 850 4/CS

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is not available for return, as it was discarded.However, the customer sent the photograph of the portion of circuit that required to be taped to ensure it was tight.No root cause has been determined at this time, since investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the circuit 3100a is too loose.As an intervention, they tape the up the loose part.At this time, there is no information regarding patient harm.

Manufacturer Narrative

Device evaluation: d4, g4, g7, h2, h4, h6 and h10.Investigation results: the device history record (dhr) review and confirmation of photos show no deviations to manufacturer specification.Internal process was reviewed and found no issues that could be linked with this failure.

• Brand Name: CIRCUIT 3100A 38IN F&P 850 4/CS
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9813167
• MDR Text Key: 188824621
• Report Number: 8030673-2020-00089
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446003397
• UDI-Public: (01)20846446003397(10)00004111999
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CIRCUIT 3100A 38IN F&P 850 4/CS
• Device Catalogue Number: 773996
• Device Lot Number: 0004111999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention