MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION ASV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	FRX1130S14
Medical Device Problem Codes	Overheating of Device (1437); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was contacted in reference to a thermal product malfunction.The manufacturer received information alleging overheating or arcing.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.During the technician's repair, the technician noticed overheating or arcing at the power supply connection.The technician reported the device was destroyed.Should additional relevant information become available, a follow-up report will be submitted.
Additional Manufacturer Narrative
In previously submitted report, fda product code, common device name, remedial action init (rfb), recall (z) number (rfb) was incorrect.In this report, after reviewing information, fda product code, common device name, remedial action init (rfb), recall (z) number (rfb) has been updated and corrected.

• Brand Name: DREAMSTATION ASV
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 21938004
• Report Number: 2518422-2025-104923
• Device Sequence Number: 12735826
• Product Code: MNS
• UDI-Device Identifier: 00606959426450
• UDI-Public: (01)00606959426450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: Lay User/Patient
• Device Model Number: FRX1130S14
• Device Catalogue Number: FRX1130S14
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown