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

Model Number J168494210AEC

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problems Sore Throat (2396); Cough (4457)

Event Date 07/01/2017

Event Type  Injury  

Event Description

Chronic cough and burning in the throat from the philips cpap.Started after using it and continued.Had mold in the machine and damage due to the recall.Fda safety report id# (b)(4).

• Brand Name: PHILIPS DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14488280
• MDR Text Key: 292595796
• Report Number: MW5109848
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: J168494210AEC
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Ethnicity: Non Hispanic
• Patient Race: White