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

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/09/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 299693603
• Report Number: 8030673-2022-00247
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003192
• UDI-Public: (01)10846446003192(11)20180530(10)0004038692
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1