FDA Adverse Event
Malfunction
Summary report: N
PHILIPS CPAP DEVICE
MDR report key: 18868737
·
Received March 8, 2024
Report
- Report Number
- 2518422-2024-12844
- Event Type
- Malfunction
- Date Received
- March 8, 2024
- Date of Event
- March 5, 2024
- Report Date
- June 12, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.
Additional Manufacturer Narrative · 0
IN THIS REPORT, SECTION H - DEVICE PROBLEM CODE HAS BEEN UPDATED.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5151580) IN WHICH THE PATIENT ALLEGES INCREASED EYE AND NOSE IRRITATION AND ALSO AROUND MY MOUTH. THE PATIENT ALSO SAID THAT HIS/HER EYES ARE SWELLING AND HAVE BECOME INFECTED. THE PATIENT USED CORTISONE CREAM AT THE RIGHT OF HIS/HER EYES DUE TO ITCHY AND IRRITATION. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168547 | PHILIPS CPAP DEVICE | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX520H11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |