MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. PHILIPS BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Myocardial Infarction (1969); Tinnitus (2103); Hallucination (4428); Myocardial Hypertrophy (4447); Unspecified Respiratory Problem (4464)

Event Date 01/01/2021

Event Type  Death  

Event Description

My brother had copd (chronic obstructive pulmonary disease) and had been visiting my brother in indiana.He was hospitalized in (b)(6), and a few days later returned to my home in (b)(6) still very sick.He was prescribed one of the bipap machines after being hospitalized again in (b)(6).My brother became so ill after that, he was never the same until his death.At that time we did not know about a recall until just a few days before his death we received a letter.My brothers breathing became worse, he was on oxygen 24/7 and at times set it on it on 4% just to be able to breath.He used a recall machine 4-6 times daily.He talked out of his head.He said every day that he felt someone shocking him.He said when wearing the bipap or even his o2 at this point that someone was constantly shocking him.He would hallucinate, never sleep because he heard voices or ringing in his ears.He even call 911 several times because he thought we were "shocking" him all the time.He suffered daily, every day was a struggle for him, not just due to copd, but more so mentally.Again, we knew nothing about a recall, we tried several times to get him to his doctor, but he refused because he did not trust any of us.I reported it to his doctor and the company that gave him the machine.I reported it to his respiratory therapist as well.Again, no word on the machine causing such potential effects.He constantly struggled to breath, and had a severe headaches.He moved back in with his wife and within just days was hospitalized again.That is when we finally got a letter about the recall.But it was to late.His heart was three times larger than his chest cavity we were told.We were also told that he was dying.The hospital sent him home and within a few more days his heart just busted.He was 57 years old.He had a severe massive heart attack.To this day i believe that bipap caused his death now.I know for a fact that as soon as he started on the bipap, his health rapidly declined.I don't have his medical records to prove anything, but i know.I just hope that by sending this that it will save someone's life and they don't have to suffer like my brother suffered.

• Brand Name: PHILIPS BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16378680
• MDR Text Key: 309651514
• Report Number: MW5114928
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White