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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Respiratory Failure (2484)

Event Date 02/27/2023

Event Type  Injury  

Event Description

Patient's caretaker (mother, (b)(6)) called to report about the bipap machine her son is using.The first bipap machine broke in (b)(6) 2022 so her son was without a bipap for two months.The second machine was received around january 15, 2023.After use of the replaced bipap, her son became very sick and was admitted into the hospital (icu) for pulmonary failure and systemic infection (teeth, skin, stomach and blood).Patient was treated with antibiotics and steriods and was released after one week in hospital on (b)(6) 2023.When rotech attempted to download her son's sleep data (from the card), it still had the previous user's name on the card which prevented recording of her son's sleep information.Reporter believes her son became sick due to the reconditioned machine not being properly cleaned/disinfected from use by the previous owner.When reporter attempted to get help/assistance from rotech, they were "very rude and unhelpful".Reporter's son is now using a bipap machine with another company and is doing better.

• Brand Name: ROTECH BIPAP MACHINE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 16565385
• MDR Text Key: 311574026
• Report Number: MW5115793
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 134 KG