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

Model Number 150P

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Myocardial Infarction (1969); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

Began using philips remstar cpap in 2012.Heart attacks in 2019.Has respiratory issues and headaches as a result of cpap usage.

• Brand Name: REMSTAR CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17282158
• MDR Text Key: 318663197
• Report Number: MW5119200
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 150P
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HIGH BLOOD PRESSURE MEDICATION ; METFORMIN
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male