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
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9813167
• Report Number: 8030673-2020-00089
• Device Sequence Number: 10915154
• Product Code: LSZ
• UDI-Device Identifier: 20846446003397
• UDI-Public: (01)20846446003397(10)00004111999
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: CIRCUIT 3100A 38IN F&P 850 4/CS
• Device Catalogue Number: 773996
• Device Lot Number: 0004111999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention