MAUDE Adverse Event Report: GVS FILTER TECHNOLOGY UK LTD HME FILTER - ADULT 50PK; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 24967

Device Problems Insufficient Flow or Under Infusion (2182); Moisture or Humidity Problem (2986)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the filter to be returned so that an engineering investigation can be performed.The product has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a trached patient using an astral 150 device with heat and moisture exchange filter (hmef) experienced desaturation of oxygen allegedly due to water saturation of the hmef which led to a drop in flow.The hmef had been in use for 18 hours when the incident occurred.The hmef was replaced with another filter on the same device and the issue resolved.There are no allegations of malfunction against the astral device.

• Brand Name: HME FILTER - ADULT 50PK
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): GVS FILTER TECHNOLOGY UK LTD; nfc house, mellishaw lane; morecambe, lancashire LA33E N; UK LA33EN
• MDR Report Key: 17975726
• MDR Text Key: 326158533
• Report Number: 3004604967-2023-00588
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24967
• Device Catalogue Number: 24967
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2023
• Distributor Facility Aware Date: 09/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other