LIFE2000 VENTILATOR PACKAGED
Report
- Report Number
- 1316463-2023-00104
- Event Type
- Death
- Date Received
- May 2, 2023
- Date of Event
- February 17, 2023
- Report Date
- May 2, 2023
- Manufacturer
- WELCH ALLYN INC
- Product Code
- CBK
- PMA / PMN Number
- K170037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
IT WAS REPORTED BY THE PATIENT¿S WIFE AFTER RECEIVING THE FIELD ACTION (FA) LETTER THAT THE PATIENT DIED WHILE CONNECTED TO THE LIFE2000 AND SHE BELIEVES THE DEVICE CAUSED HIS DEATH. THE PATIENT IN THIS EVENT IS A 95-YEAR-OLD MALE WITH A MEDICAL HISTORY OF CONGESTIVE HEART FAILURE, CHRONIC KIDNEY DISEASE STAGE 3B, HYPERTENSION, PULMONARY HYPERTENSION, COPD ON 3 LPM OF O2, STROKE WITH LEFT HEMIPARESIS AND LEFT-SIDED WEAKNESS, CORONARY HEART DISEASE, BENIGN PROSTATIC HYPERTROPHY, OBSTRUCTIVE SLEEP APNEA, RESPIRATORY ARREST, POSSIBLE ATRIAL FIBRILLATION ON ELIQUIS, RECENT HOSPITALIZATION WITH PNEUMONIA, RESPIRATORY ARREST REQUIRING VENTILATOR, HEART ATTACK, MULTIFOCAL STROKE FROM MULTIPLE CLOTS (B)(6) 2021 TO (B)(6) 2021. AS REPORTED IN THE PROGRESS NOTE FROM PALLIATIVE CARE ON (B)(6) 2023, PATIENT WAS ON 6L OF OXYGEN VIA NASAL CANNULA AND BREATHING WAS NOTED TO BE LABORED WITH USE OF ACCESSORY MUSCLES. ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH ACUTE WORSENING SHORTNESS OF BREATH AND REMAINED HYPOXIC IN THE EMERGENCY ROOM REQUIRING A NON-REBREATHER AND HIGH FLOW O2. THE PATIENT WAS CULTURE POSITIVE FOR STREPTOCOCCUS MITIS AND ORALIS AND WAS DIAGNOSED WITH PNEUMONIA AND SEPSIS. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED TO A LONG-TERM ACUTE CARE FACILITY. ON (B)(6) 2023, THERAPY ON THE LIFE2000 WAS INITIATED AND PER THE PATIENT¿S WIFE, THE PATIENT WAS DISCHARGED HOME AND BELIEVED HE WAS ON 8L OF O2 (THIS LITER FLOW DIFFERS FROM WHAT WAS PRESCRIBED AT TIME OF DISCHARGE, WHICH WAS 6 LPM). THE PATIENT RESUMED USE OF THE LIFE2000 AT HOME WITH A RESPIRONICS 10 LITER OXYGEN CONCENTRATOR. AT THE TIME OF DISCHARGE, THE PATIENT WAS NOT ON ANTIBIOTICS AND HAD NO ACTIVE INFECTION OR FEVER. ON (B)(6) 2023 AROUND 10:00 OR 11:00 PM, THE PATIENT BEGAN HAVING OXYGEN DESATURATION EPISODES RANGING FROM 60-90%. THE CAREGIVER COACHED THE PATIENT THROUGH THESE EPISODES AND THE PATIENT REFUSED TO GO BACK TO THE HOSPITAL. THE PATIENT WAS SHORT OF BREATH AND OXYGEN SATURATIONS CONTINUED TO FLUCTUATE THROUGHOUT THE NIGHT AND THEY NEVER WENT TO BED. THE PATIENT¿S WIFE INCREASED THE SETTING ON THE LIFE2000 TO THE HIGHEST SETTING; THE NASAL INTERFACE AND COMBO HOSE WAS NEW AND HAD JUST BEEN TAKEN OUT OF THE PACKAGE ON (B)(6) 2023. ON (B)(6) 2023 AROUND 5:20 AM, THE PATIENT WAS ASSISTED TO THE BATHROOM WITH HELP FROM HIS WIFE AND HOME AID AND THE PATIENT PASSED AWAY ON THE TOILET WHILE CONNECTED TO THE LIFE2000 DEVICE. THE PATIENT¿S WIFE CALLED 911 AND ALTHOUGH THE PATIENT WAS DO NOT RESUSCITATE (DNR) (WIFE DID NOT HAVE THE ORDER AT HOME), RESUSCITATION WAS ATTEMPTED, AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE HE WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS REPORTED AS CARDIOPULMONARY FAILURE. THE PATIENT¿S WIFE STATED SHE NEVER NOTICED THE BALL ON THE OXYGEN CONCENTRATOR MOVING OR KINKED TUBING AS SHE WAS NOT AWARE SHE NEEDED TO MONITOR THIS UNTIL SHE AFTER RECEIVED THE BAXTER FA LETTER. THERE WERE NO ALARMS NOTED ON THE VENTILATOR, COMPRESSOR, OR OXYGEN CONCENTRATOR DURING THIS EVENT. THE PATIENT¿S WIFE STATED THE DEVICE WAS PICKED UP BY THE TRAINER ON AN UNKNOWN DATE AND SHE DID NOT PROVIDE ANY DETAILS OF THE PATIENT¿S DEATH AS SHE WAS UNAWARE OF THE BAXTER FA LETTER AT THAT TIME. DEVICE SETTINGS WERE AS FOLLOWS: VT: 180; I-TIME: 0.75; PEEP: 1; SENS: 1; BR: 12. THE HILLROM RESPIRATORY CLINICIAN ADDRESSED ALL QUESTIONS AND CONCERNS. 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 DEVICE INSTRUCTIONS FOR USE STATE ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. HILLROM RECEIVED THE LIFE2000 VENTILATOR FOR INSPECTION. THE VENTILATOR WAS SET UP IN AN EXTENDED RANGE CONFIGURATION USING A KNOWN GOOD COMBO HOSE, PATIENT CIRCUIT, AND COMPRESSOR. USING AN INVACARE PLATINUM XL 5 LITER OXYGEN CONCENTRATOR, 5 LITERS OF OXYGEN WAS BLED IN, AND THERAPIES WERE RUN AT LOW, MEDIUM, AND HIGH ACTIVITY LEVELS. THE FLOW METER ON THE OXYGEN CONCENTRATOR DID NOT DROP BELOW THE 5 LPM SET POINT. NO ERROR MESSAGE, ALARMS, OR MALFUNCTIONS WERE IDENTIFIED; THE VENTILATOR FUNCTIONED AS INTENDED. IN THIS EVENT, THE PATIENT¿S CAUSE OF DEATH WAS REPORTED AS CARDIOPULMONARY FAILURE AND THE PATIENT WAS IN PALLIATIVE CARE AND REPORTED TO BE DNR AT THE TIME OF DEATH. IT CAN REASONABLY BE CONCLUDED THAT THE PATIENT¿S EXTENSIVE MEDICAL HISTORY AND AGE WERE KEY FACTORS IN HIS DEATH; HOWEVER, ALTHOUGH THE DEVICE FUNCTIONED AS DESIGNED DURING INSPECTION, THE PATIENT WAS CONNECTED TO THE LIFE2000 AT THE TIME OF THE EVENT. THEREFORE, IT CANNOT BE EXCLUDED THAT A POSSIBLE LESSOR CONTRIBUTORY FACTOR WAS A SYSTEM INTERACTION/MALFUNCTION BETWEEN THE LIFE2000 AND THIRD-PARTY VENDOR CONCENTRATOR THAT MAY LEAD TO OXYGEN FLOW FROM THE CONCENTRATOR FALLING BELOW THE PRESCRIBED LEVEL. ¿BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
IT WAS REPORTED BY THE PATIENT¿S WIFE AFTER RECEIVING THE FIELD ACTION (FA) LETTER THAT THE PATIENT DIED WHILE CONNECTED TO THE LIFE2000 AND SHE BELIEVES THE DEVICE CAUSED HIS DEATH. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4)..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1534141 | LIFE2000 VENTILATOR PACKAGED | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | WELCH ALLYN INC | BT-20-0002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Male | Death |