MAUDE Adverse Event Report: VYAIRE MEDICAL BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S; VENTILATOR, HIGH FREQUENCY

Model Number	BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been discarded, however the device history record review was requested to determined the root cause of the issue.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 bias gas tube with connected from the water chamber to the 11518-850s boxed patient circuit assy,31a, filtered,850s has a weak point and becomes loose after a few hours of use, which causes pressure to drop and the oscillator to stop.There is no information on patient outcome.
Additional Manufacturer Narrative
Results of investigation:the device history record was reviewed in order to detect any issue related with the reported defect during its manufacturing.The complete lot was manufactured, inspected and released per our internal procedures and no issues were found.Based on the investigation and per pictures sent by the customer we could not confirm the reported defect.Sample is needed to perform a better investigation looking for dimensional issues or assembly defects.Therefore, the root cause was not determined.Additionally, pfmea 10a was reviewed and we have the controls for this kind of issues.

• Brand Name: BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14307973
• Report Number: 8030673-2022-00247
• Device Sequence Number: 4846582
• Product Code: LSZ
• UDI-Device Identifier: 10846446003192
• UDI-Public: (01)10846446003192(11)20180530(10)0004038692
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2022

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: BOXED PATIENT CIRCUIT ASSY,31A,FILTERED,850S
• Device Catalogue Number: 11518-850S
• Device Lot Number: 0004038692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown