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

Model Number DSX700T11

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem Myocardial Infarction (1969)

Event Date 06/16/2021

Event Type  Injury  

Event Description

My philips respironics dream master bipap broke and i was able to jerry rig it to work on cpap with severe leakage.When i called to report it i was advised about the recall on the machine and they could not do anything until they could replace it with the other recalled machines.I've been calling continuously for the replacement and was assured that i have been escalated to get a machine 4 times, i was assured on numerous other occasions that it was being taken care of , and finally about a month and a half ago i was told i needed a new script.I contacted my practitioner and they sent a new script.I called again last week and they advised that they couldn't find my registration, let alone the new script, and they assured me someone would call md back.I have a heart condition for 22 years and have had a 4x bypass, and a recent heart attack.I have severe apnea and my physician attributes my heart condition to be a significant contributing factor.I have used a cpap or bipap for the last ten years every night without fail.I am currently 76 years old.My dme supplier says that they are powerless to help me.Any assistance that your department can provide to get this resolved would be greatly appreciated.My philips confirmation number is (b)(6).

• Brand Name: BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16454083
• MDR Text Key: 310586393
• Report Number: MW5115288
• 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: Patient
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX700T11
• Device Catalogue Number: DREAMSTATIONBIPAP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2023
• Patient Sequence Number: 1
• Treatment: ATROVASTATIN 80 MG ; BENADRYL 25 MG; CARVEDILOL 3.125 ; CHILD ASPIRIN ; CHLORTHALIDONE 25 MG; LOSARTAN 25MG ; MULTIVITAMIN ; NITROLINGUAL SERTRALINE 25MG ; TAMSULOSIN .4 MG
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White