LIFE2000 VENTILATOR PACKAGED
Report
- Report Number
- 1316463-2023-00109
- Event Type
- Injury
- Date Received
- May 9, 2023
- Date of Event
- March 22, 2023
- Report Date
- May 31, 2023
- Manufacturer
- WELCH ALLYN INC.
- Product Code
- CBK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS INSPECTED AND TESTED AND THE COMPRESSOR PERFORMED AS INTENDED. THE FLOW METER ON THE RESPIRONICS OXYGEN CONCENTRATOR DID NOT DROP BELOW THE 5 LPM SET POINT. THE TECHNICIAN DID NOT FIND ANY EVIDENCE THAT THE SUBMITTED LIFE2000 DEVICE CONTRIBUTED TO THE ALLEGED INJURY AS THE ALLEGATIONS OF DESATURATION COULD NOT BE DUPLICATED. THE ULTIMATE CAUSE OF THE REPORTED DROP IN OXYGEN SATURATION IS UNKNOWN, BUT A SYSTEM INTERACTION/MALFUNCTION BETWEEN THE LIFE2000 AND THIRD-PARTY VENDOR CONCENTRATOR CAN NOT BE RULED OUT AT THIS TIME. IF THIS SYSTEM INTERACTION/MALFUNCTION WERE TO RECUR, IT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
THE PATIENT IN THIS EVENT IS A 73-YEAR-OLD FEMALE WITH A MEDICAL HISTORY OF COPD AND CHRONIC RESPIRATORY FAILURE. THE PATIENT STATED SHE HAD NOT BEEN FEELING WELL ALL DAY PRIOR TO THE REPORTED EVENT AND HER HEALTH HAD BEEN DECLINING. AT THE TIME OF THE EVENT, THE PATIENT WAS IN THE BATHROOM AND CONNECTED TO THE LIFE2000 AND AN OXYGEN CONCENTRATOR (UNKNOWN MANUFACTURER/MODEL) WHEN SHE BEGAN TO FEEL LIGHT-HEADED. SHE LOOKED AT THE LIFE2000 VENTILATOR AND NOTICED NO NUMBERS WERE DISPLAYED ON THE SCREEN AND THERE WAS NO AIR FLOW. THE PATIENT COULD NOT RECALL IF THE LIFE2000 PROVIDED ANY TYPE OF ALARM. THE PATIENT CALLED HER DAUGHTER FOR HELP AND THE PATIENT¿S OXYGEN SATURATION WAS 69%. THE PATIENT WAS DISCONNECTED FROM THE LIFE2000 VENTILATOR AND SWITCHED TO A ¿NON-REBREATHER OXYGEN DEVICE.¿ THE PATIENT¿S DAUGHTER ALSO INCREASED THE OXYGEN FLOW FROM THE PRESCRIBED SET POINT OF 4 LPM TO 6 LPM. THE PATIENT COULD NOT RECALL HOW LONG IT TOOK TO RECOVER OR WHAT HER OXYGEN SATURATION WAS WHEN SHE RECOVERED. THE FOLLOWING DAY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR WHAT HER HEALTHCARE TEAM THOUGHT WAS A COPD EXACERBATION. WHILE HOSPITALIZED, THE PATIENT WAS ON HIGH FLOW OXYGEN AND BIPAP AT NIGHT. THE PATIENT¿S DAUGHTER ALLEGED THE LIFE2000 CAUSED THE PATIENT TO DESATURATE WHICH LED TO THE PATIENT BEING HOSPITALIZED FOR FIVE DAYS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND PLACED ON HOSPICE CARE DUE TO HER DECLINE IN HEALTH. THE PATIENT INQUIRED ABOUT USING THE LIFE2000 WITH TWO OXYGEN CONCENTRATORS (AS PRESCRIBED AT THE TIME OF DISCHARGE) AND THE HILLROM RESPIRATORY CLINICIAN ADVISED A TRAINER VISIT WOULD BE SCHEDULED. THE PATIENT HAD NOT USED TWO CONCENTRATORS WITH THE LIFE2000. A HILLROM TRAINER VISITED THE PATIENT AFTER SHE WAS DISCHARGED FROM THE HOSPITAL TO ADJUST THE DEVICE PRESSURE SETTINGS AND TO SET UP A UNIVERSAL CIRCUIT CONNECTOR ADAPTER WITH THE PATIENT OWNED BIPAP MASK. NO ISSUES WERE NOTED WITH THE LIFE2000 VENTILATOR AT THAT TIME. THE FOLLOWING DAY, THE LIFE2000 ALARMED FOR LOW PRESSURE. THE PATIENT AND HER DAUGHTER WERE NOT WILLING TO TROUBLESHOOT THE ALARM AND IT WAS CONFIRMED THAT HOSPICE WOULD NOT COVER THE COST OF THE LIFE2000, AND THE PATIENT WAS SWITCHED TO BIPAP. THE LIFE2000 WAS SCHEDULED TO BE PICKED UP AND RETURNED TO HILLROM. THE BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. SPECIFICALLY, THE SYSTEM IS APPLICABLE FOR ADULT PATIENTS WHO REQUIRE THE FOLLOWING TYPES OF VENTILATORY SUPPORT: POSITIVE PRESSURE VENTILATION, DELIVERED INVASIVELY (VIA ET TUBE) OR NON-INVASIVELY (VIA MASK). ASSIST/CONTROL MODE OF VENTILATION. THE LIFE2000 VENTILATION SYSTEM REQUIRES THE USE OF EITHER THE UNIVERSAL CIRCUIT CONNECTOR OR BREATHE PILLOWS ENTRAINMENT INTERFACE. THE UNIVERSAL CIRCUIT CONNECTOR IS USED TO CONNECT ANY COMMERCIALLY AVAILABLE NON-INVASIVE MASK (FULL FACE, NASAL, OR PILLOWS) OR TRACHEOSTOMY TUBE TO A HILLROM VENTILATOR OR COMPRESSOR. A LOW PIP PRESSURE ALARM CAN OCCUR WHEN THE PEAK INSPIRATORY PRESSURE (PIP) IS BELOW THE SET LIMIT AND TROUBLESHOOTING STEPS TO ADDRESS THIS ALARM ARE OUTLINED IN THE DEVICE INSTRUCTIONS FOR USE (IFU). THE DEVICE IFU STATES ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. OXYGEN DESATURATION IS A BELOW-NORMAL LEVEL OF OXYGEN IN THE BLOOD. NORMAL PULSE OXIMETER READINGS RANGE FROM 94 TO 100 PERCENT A VALUE UNDER 90 PERCENT IS CONSIDERED LOW. OXYGEN DESATURATION CAN BE CONTRIBUTED TO DISORDERS SUCH AS COPD, EMPHYSEMA, RESPIRATORY FAILURE, OR OTHER PULMONARY DISORDERS. TREATMENT TYPICALLY CONSISTS OF OXYGEN MEASUREMENT (VIA BLOOD TEST OR PULSE OXIMETRY) AND OXYGEN ADMINISTRATION. IN THIS EVENT, THE PATIENT¿S OXYGEN LEVEL WAS CLINICALLY BELOW NORMAL RANGE, AND THE PATIENT WAS SWITCHED TO AN ALTERNATE MEANS OF OXYGEN THERAPY. THE PATIENT RECOVERED WITH MEDICAL INTERVENTION WHICH INCLUDED AN INCREASE IN OXYGEN FLOW FROM THE PRESCRIBED SET POINT OF 4 LPM TO 6 LPM VIA NON-REBREATHER OXYGEN DEVICE. THE EVENT OF OXYGEN DESATURATION TO 69% ACCOMPANIED BY THE PATIENT FEELING LIGHT-HEADED IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED IN THIS CASE. ADDITIONALLY, THE PATIENT¿S DAUGHTER ALLEGED THE LIFE2000 DEVICE CAUSED THE PATIENT TO BE HOSPITALIZED (MEDICAL INTERVENTION) FOR THE EVENT OF OXYGEN DESATURATION. THE CAUSE OF THE REPORTED EVENT IS UNKNOWN BUT LIKELY MULTIFACTORIAL DUE TO THE PATIENT¿S UNDERLYING PULMONARY PATHOLOGY AND HISTORY OF DECLINING HEALTH PRIOR TO THE EVENT. AN INSPECTION OF THE DEVICE IS PENDING, AND A MALFUNCTION CANNOT BE RULED OUT AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT WILL BE REASSESSED.
IT WAS REPORTED THAT PATIENT BECAME LIGHT-HEADED WHILE USING THE LIFE2000 DEVICE AND DESATURATED TO 69%. THE PATIENT STATED THERE WERE NO NUMBERS DISPLAYED ON THE LIFE2000 SCREEN AND NO AIR FLOW. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED THE FOLLOWING DAY. THIS INCIDENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).
IT WAS REPORTED THAT PATIENT BECAME LIGHT-HEADED WHILE USING THE LIFE2000 DEVICE AND DESATURATED TO 69%. THE PATIENT STATED THERE WERE NO NUMBERS DISPLAYED ON THE LIFE2000 SCREEN AND NO AIR FLOW. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED THE FOLLOWING DAY. THIS INCIDENT WAS CAPTURED UNDER HILL-ROM COMPLAINT REF # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1954252 | LIFE2000 VENTILATOR PACKAGED | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | WELCH ALLYN INC. | BT-20-0002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |