MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR HEATED HUMIDIFIER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	1056209
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Swelling/ Edema (4577); Limb Pain (4836)
Date of Event	09/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging dvt (deep vein thrombosis) with the leg swelling dramatically and leg pain so intense the patient could barely walk.Medical intervention was specified as being prescribed blood thinners for 6 months during which time the leg of the patient slowly returned to normal.The patient claimed to have used the device for over 5 years and suspended use upon hearing of the recall.The dvt occurred within one month of suspending use of the device.Approximately 13 months later (date not specified), the patient experienced another dvt after injuring the leg while moving furniture.The patient was subsequently recommended to remain on blood thinners indefinitely.The patient had unspecified tests performed to attempt to determine the cause of the dvt, but testing was unsuccessful in diagnosing the cause.The patient claims to have no personal or family history of clots, and attributes the events as occurring following the suspension of use of the device.The patient stated this experience has forever altered the course of the patient's life.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
Additional Manufacturer Narrative
The manufacturer previously reported that the manufacturer was contacted in reference to the voluntary field safety notice/recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging dvt (deep vein thrombosis) with the leg swelling dramatically and leg pain so intense the patient could barely walk.Medical intervention was specified as being prescribed blood thinners for 6 months during which time the leg of the patient slowly returned to normal.The patient claimed to have used the device for over 5 years and suspended use upon hearing of the recall.The dvt occurred within one month of suspending use of the device.Approximately 13 months later (date not specified), the patient experienced another dvt after injuring the leg while moving furniture.The patient was subsequently recommended to remain on blood thinners indefinitely.The patient had unspecified tests performed to attempt to determine the cause of the dvt, but testing was unsuccessful in diagnosing the cause.The patient claims to have no personal or family history of clots, and attributes the events as occurring following the suspension of use of the device.The patient stated this experience has forever altered the course of the patient's life.The product associated with this complaint was not returned to the manufacturer.This report is being sent to conclude that no further investigation is possible.No device has been returned.No further evaluation is possible at this time.Multiple attempts to have the device returned for evaluation and investigation were unsuccessful.In addition, capa pr 7211 documents the investigation into similar complaints, correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance, and as an input to risk management activities.

• Brand Name: REMSTAR HEATED HUMIDIFIER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20480490
• Report Number: 2518422-2024-102270
• Device Sequence Number: 8275793
• Product Code: BZD
• UDI-Device Identifier: 00606959004108
• UDI-Public: (01)00606959004108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: Lay User/Patient
• Device Model Number: 1056209
• Device Catalogue Number: 1056209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White