MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. REMSTAR AUTO A-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Particulates (1451)

Patient Problems Pulmonary Embolism (1498); Coagulation Disorder (1779); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Cpap recalled.I've used it for several years, and had an unexplained dvt and multiple clots, and pulmonary embolisms.I am wondering now if particles from the toxic foam in the cpap are what led to my coagulation issue.Fda safety report id # (b)(4).

• Brand Name: REMSTAR AUTO A-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12703945
• MDR Text Key: 278800997
• Report Number: MW5104969
• Device Sequence Number: 1
• Product Code: BZD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 95