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

Device Problems Component Missing (2306); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Received philips respironics dreamstation1 to replace recalled systemone unit.Replacement unit was defective in that it did not have a power supply.Called philips at the time.They do not as of this date have a power supply for replacement.They shipped a defective unit.As of this date, there is no eta (estimated time of arrival) for a fix/replacement of defective units.Reference report: mw5118047.

• Brand Name: SYSTEM ONE CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 17050224
• MDR Text Key: 316503231
• Report Number: MW5118048
• 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: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 138 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White