DREAMSTATION AUTO BIPAP
Report
- Report Number
- 2518422-2022-00259
- Event Type
- Injury
- Date Received
- January 5, 2022
- Date of Event
- December 28, 2021
- Report Date
- October 31, 2023
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K131982
- Removal / Correction Number
- RES 88058
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED HEART ISSUES AND HAS BEEN ADMITTED TO HOSPITAL SEVERAL TIMES RECENTLY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR FURTHER INVESTIGATION. USING A KNOWN GOOD POWER SUPPLY AND POWER CABLE, PIL VERIFIED THE BASE UNIT PROVIDED AIRFLOW AND THE HEATER PLATE HEATS. EXTERIOR INVESTIGATION: THERE IS UNKNOWN DUST/DIRT CONTAMINATION PRESENT ON ALL SURFACES OF THE BASE UNIT AND HUMIDIFIER BASE. THE DEVICE DID NOT RETURN WITH AN SD CARD OR FILTER, THE HUMIDIFIER BASE DID NOT RETURN WITH A WATER TANK. THERE IS AN UNKNOWN DUST CONTAMINATE PRESENT AT THE AIR INLET WHERE THE FILTER WOULD BE AND AT THE ISO PORT ENTRANCE WHERE THE BASE MATES WITH THE HUMIDIFIER. INTERIOR INVESTIGATION: THERE ARE MINERAL DEPOSITS PRESENT ON THE MOTOR CASING SUGGESTING UNKNOWN LIQUID INGRESS. THERE IS AN UNKNOWN WHITE DUST CONTAMINATION FOUND ON THE BOTTOM ENCLOSURE, BLOWER BOX HOUSING, BLOWER MOTOR, BLOWER IMPELLER, AND REAR PANEL O-RING. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED IN THE BASE UNIT. SECONDARY FINDINGS: DEVICE READS: 1 ERROR, 3439.2 BLOWER AND 3363.5 THERAPY HOURS. E130 [ERR_TASK_WDOG_TIMEOUT] OCCURRED 1 TIME AND IS A REBOOT LEVEL ERROR. THIS DOES NOT IMPACT THE FINDINGS OF THIS INVESTIGATION AND WILL BE DISREGARDED. PER 2222280 (V.06): A TASK DID NOT RELOAD ITS WATCHDOG TIMER BEFORE THE WATCHDOG TIMER EXPIRED. THE TASK MAY HAVE BEEN DEADLOCKED, STARVED, IN AN INFINITE LOOP OR IN SOME OTHER STATE THAT PREVENTED IT FROM RELOADING ITS WATCHDOG TIMER. CARE ORCHESTRATOR DATA SHOWS THE PATIENT HAD A COMPLIANCE RATE OF 43.3% AND USED THE ADAPTIVE HUMIDIFICATION SETTING 5 DURING THE MOST RECENT 90 DAYS OF USE. THE UNKNOWN DUST/DIRT CONTAMINATION AND FIBERS FOUND ON THE BLOWER CASING/IMPELLER AND BLOWER BOX WAS INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM CONTAMINATION. THE PRESENCE OF CONTAMINATION THROUGHOUT THE AIRPATH SUGGESTS A SOURCE EXTERNAL TO THE DEVICE. MINERAL SPOTS CONSISTENT WITH WATER INGRESS WERE FOUND ON MOTOR CASING. WATER INGRESS HAS BEEN PREVIOUSLY ADDRESSED IN INV1023. PIL IS UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS OUTLINED IN THE COMPLAINT. PIL CAN CONFIRM THAT THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN OBSERVED IN THE BASE UNIT. PIL CAN CONFIRM THE PRESENCE OF CONTAMINATION IN THE AIRPATH. POSSIBLE RISK TAGS (ER 2219697 (V.20)) ASSOCIATED WITH THESE MODES OF FAILURE INCLUDE: IRRIT02, IRRIT03, INFECT02 AND INFECT01. THE RESULTS OF THIS INVESTIGATION DO NOT IMPACT THE CALCULATED RISKS.
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED HEART ISSUES. THE PATIENT DID RECEIVE MEDICAL INTERVENTION AND REPORTED TO HAVE BEEN ADMITTED TO THE HOSPITAL SEVERAL TIMES. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181231 | DREAMSTATION AUTO BIPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX700T11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| H |