MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR AUTO; VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)

Model Number DS560TS

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/21/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event 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 respiratory tract irritation, kidney disease/toxicity, reduced cardiopulmonary reserve other shortness of breath, extreme high blood pressure, kidney issues (stopped urinating), premature heartbeat, panic attacks.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: REMSTAR AUTO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIR ATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19042104
• MDR Text Key: 339384716
• Report Number: 2518422-2024-17317
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959005907
• UDI-Public: 00606959005907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS560TS
• Device Catalogue Number: DS560TS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other