PHILIPS CPAP DEVICE
Report
- Report Number
- 2518422-2024-102673
- Event Type
- Malfunction
- Date Received
- October 28, 2024
- Date of Event
- October 1, 2024
- Report Date
- May 12, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
IT WAS PREVIOUSLY REPORTED THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT A PATIENT EXPERIENCED EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND WAS ON TWO ASTHMA PUMPS WHILE USING AN UNSPECIFIED PHILIPS DEVICE. THE ALLEGATION HAS BEEN REVIEWED BY A PMS CLINICAL EXPERT AND DETERMINED THAT THE ALLEGATION OF EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND BEING ON TWO ASTHMA PUMPS DOES NOT QUALIFY AS A SERIOUS INJURY. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO THE REPORTED ALLEGATION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY. THIS FOLLOW UP IS TO CORRECT THE PREVIOUS REPORT THAT A FOLLOW UP WOULD BE SUBMITTED. NO DEVICE HAS BEEN RETURNED, AND NO CUSTOMER CONTACT INFO IS AVAILABLE TO PERFORM GFE FOR FURTHER INFO AT THIS TIME. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED. THE AFFECTED PRODUCTS WITH FIELD COMPLAINTS ALLEGING PE-PUR FOAM DEGRADATION HAVE UNDERGONE THE ESTABLISHMENT OF COMPLAINT CODES SPECIFICALLY IDENTIFYING FOAM DEGRADATION, FOR DREAM STATION CPAP/BIPAP SERIES. A FIELD CORRECTION ACTION(2021-06-A) WAS INITIATED, AND MEDICAL DEVICE RECALL LETTERS WERE ISSUED. A FIELD ACTION WAS INITIATED TO REPLACE PE-PUR FOAM IN AFFECTED PRODUCTS; DEGRADATION WAS ADDED TO THE RESPECTIVE DFMEAS AND THE RISK MANAGEMENT FILE THAT WAS CURRENT AT THE TIME ¿ ER 2219697 V15 (NIRVANA RISK MANAGEMENT MATRIX) WAS UPDATED TO INCLUDE HAZARDS ASSOCIATED WITH FOAM DEGRADATION BASED ON COMPLAINTS ANALYZED THROUGH VARIOUS HEALTH HAZARD EVALUATIONS (HHES). RISK TAGS ¿ DEGRAD04, IRRIT05 REFLECTED THE SAFETY RISK ASSESSMENT OF DESIGN CONTAINING THE AFFECTED PE-PUR FOAM. THESE COMPLAINTS WERE MONITORED AND TRENDED IN ACCORDANCE WITH THE COMPLAINT TRENDING PROCEDURES. IF THE COMPLAINTS WERE DETERMINED TO MEET THE CRITERIA FOR ESCALATION, THEY WERE ESCALATED FOR RISK ASSESSMENT THROUGH THE POST MARKET CLINICAL ESCALATION PROCESS. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAVE LED TO UNACCEPTABLE LEVELS OF SEVERITY OR PROBABILITIES OF HARM, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED.
THIS RECORD WAS UPDATED IN THE "TYPE OF REPORTED COMPLAINT" FIELD, THE "ADVERSE EVENT/PRODUCT PROBLEM" AND "OUTCOMES ATTRIBUTED TO AE" FIELDS FROM A SERIOUS INJURY TO A PRODUCT PROBLEM AS IT WAS SUBMITTED BY A PATIENT REPRESENTATIVE IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT A PATIENT EXPERIENCED EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND WAS ON TWO ASTHMA PUMPS WHILE USING AN UNSPECIFIED PHILIPS DEVICE. THE ALLEGATION HAS BEEN REVIEWED BY A PMS CLINICAL EXPERT AND DETERMINED THAT THE ALLEGATION OF EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND BEING ON TWO ASTHMA PUMPS DOES NOT QUALIFY AS A SERIOUS INJURY. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO THE REPORTED ALLEGATION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY.
SINCE NO DEVICE INFORMATION WAS PROVIDED, THE EXACT RECALL NUMBER IS UNKNOWN. POSSIBLE RECALL NUMBERS INCLUDE Z-1972-2021, Z-1973-2021, AND Z-1974-2021.
THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT A PATIENT EXPERIENCED EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND WAS ON TWO ASTHMA PUMPS WHILE USING AN UNSPECIFIED PHILIPS DEVICE. THE ALLEGATION HAS BEEN REVIEWED BY A PMS CLINICAL EXPERT AND DETERMINED THAT THE ALLEGATION OF EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND BEING ON TWO ASTHMA PUMPS DOES NOT QUALIFY AS A SERIOUS INJURY. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO THE REPORTED ALLEGATION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY. NO DEVICE HAS BEEN RETURNED AND NO CUSTOMER CONTACT INFO IS AVAILABLE TO PERFORM GFE FOR FURTHER INFO AT THIS TIME. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.
THIS NOTIFICATION WAS OPENED FOR REVIEW FOR INFORMATION RECEIVED THAT A PATIENT EXPERIENCED EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND WAS ON TWO ASTHMA PUMPS WHILE USING AN UNSPECIFIED PHILIPS DEVICE. THE ALLEGATION HAS BEEN REVIEWED BY A PMS CLINICAL EXPERT AND DETERMINED THAT THE ALLEGATION OF EYE IRRITATION, KIDNEY NODULES, LUNG PROBLEMS, LUNG NODULES, INSOMNIA, HIGH CPK BLOOD, HIGH LDH BLOOD, AND BEING ON TWO ASTHMA PUMPS DOES NOT QUALIFY AS A SERIOUS INJURY. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO THE REPORTED ALLEGATION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY.
THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THIS COMPLAINT HAS BEEN REVIEWED AND WILL BE REPORTED AS A SERIOUS INJURY AS THE EVENTS MEET THE DEFINITION OF A REPORTABLE COMPLAINT PER THE FDA REGULATIONS (21 CFR 803). AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. A REPORT WILL BE FILED WITH ALL APPLICABLE REGULATORY AGENCIES. THE MANUFACTURER'S INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281426 | PHILIPS CPAP DEVICE | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |