LIFE2000 VENTILATOR PACKAGED
Report
- Report Number
- 1316463-2023-00162
- Event Type
- Injury
- Date Received
- July 19, 2023
- Date of Event
- June 4, 2023
- Report Date
- August 14, 2023
- Manufacturer
- WELCH ALLYN INC
- Product Code
- CBK
- UDI-DI
- 00887761978201
- PMA / PMN Number
- K170037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS REPORTED THAT ON SEVERAL OCCASIONS, THE PATIENT¿S OXYGEN TUBING DISCONNECTED FROM THE LIFE2000, AND THE DEVICE DID NOT ALARM. THE PATIENT IS A 77-YEAR-OLD MALE WITH A MEDICAL HISTORY OF COPD AND CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA. PER THE PATIENT, THE REPORTED EVENT HAS OCCURRED WHEN THE PATIENT¿S WIFE ROLLED OVER THE TUBING WITH HER WHEELCHAIR, OR WHEN THE PATIENT WAS MOVING AROUND THE HOME. THE PATIENT DECLINED A TRAINER VISIT TO DETERMINE IF THE SET UP COULD BE REARRANGED IN THE HOME. PER THE PATIENT, THERE WAS NO WAY OF KNOWING WHEN THE OXYGEN TUBING BECAME DISCONNECTED UNTIL HE WAS SYMPTOMATIC/DISORIENTED WITH SPO2 INTO THE LOW 80¿S. ONCE THE PATIENT RECONNECTED THE OXYGEN TUBING TO THE LIFE2000 FROM HIS HOME OXYGEN CONCENTRATOR DELIVERING 3 LPM, HIS SPO2 RECOVERED TO BASELINE OF 96-97%. DUE TO THERE BEING NO ALARMS TO WARN OF THE DISCONNECTION BETWEEN THE LIFE2000 AND OXYGEN TUBING, THE PATIENT HAS REQUESTED TO RETURN THE DEVICE. THE PATIENT DID NOT HAVE TO SEEK MEDICAL ATTENTION FOR LOW SPO2 AS HE WAS ABLE TO QUICKLY RECOVER AT HOME. THE LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. THE DEVICE INSTRUCTION FOR USE NOTE THE FOLLOWING WARNING: IF THE BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM IS NOT FUNCTIONING PROPERLY, RESPIRATORY THERAPY MAY BE COMPROMISED AND MAY RESULT IN PATIENT HARM OR DEATH. ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING REGARDING MONITORING FOR OXYGEN ADMINISTRATION: TO ENSURE ACCURACY OF OXYGEN ADMINISTRATION AND TO MONITOR FOR THE PRESENCE OF CONTAMINATION (INCORRECT GAS CONNECTED), USE AN EXTERNAL OXYGEN MONITOR TO VERIFY THE OXYGEN CONCENTRATION IN THE DELIVERED GAS. 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, THE CHANGE WAS TEMPORARY, AND THE PATIENT RECOVERED AT HOME BY RECONNECTING THE OXYGEN TUBING TO THE LIFE2000 FROM THE OXYGEN CONCENTRATOR DELIVERING THE PRESCRIBED OXYGEN THERAPY. HOWEVER, THE EVENT OF OXYGEN DESATURATION TO THE LOW 80¿S ACCOMPANIED BY THE PATIENT BEING DISORIENTED IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED. THE ULTIMATE CAUSE OF THE REPORTED DROP IN OXYGEN SATURATION IS LIKELY MULTIFACTORIAL DUE TO THE PATIENT'S UNDERLYING PULMONARY PATHOLOGY AND OXYGEN TUBING DISCONNECTING FROM THE LIFE2000. ALTHOUGH THE PATIENT ALLEGED THE DEVICE DID NOT ALARM FOR THIS CONDITION, THE DEVICE IFU WARNS USERS TO USE AN EXTERNAL OXYGEN MONITOR TO ENSURE ACCURACY OF OXYGEN ADMINISTRATION. AT THIS TIME, A DEVICE INSPECTION IS PENDING, AND A MALFUNCTION CANNOT BE RULED OUT. THE COMPLAINT WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. 14AUG2023 CLINICAL EVALUATION UPDATE: THE LIFE20000 LIFE2000 VENTILATOR WAS RECEIVED FOR INSPECTION. THE VENTILATOR WAS SET UP IN AN EXTENDED RANGE CONFIGURATION USING A KNOWN GOOD COMBO HOSE, PATIENT CIRCUIT, AND COMPRESSOR. THERAPIES WERE PERFORMED AT LOW, MEDIUM, AND HIGH ACTIVITY LEVELS AND A LOW BREATH RATE ALARM WAS OBSERVED DUE TO THE CLINICAL SETTINGS OF BREATH RATE BEING SET TOO LOW. NO DEVICE MALFUNCTION WAS FOUND. A LOW BREATH RATE ALARM OCCURS WHEN THE RESPIRATORY RATE FALLS BELOW THE SET LIMIT. THE DEVICE IFU LISTS THE FOLLOWING POSSIBLE CAUSES AND TROUBLESHOOTING STEPS TO RESOLVE THE ALARM: THE PATIENT IS BREATHING THROUGH THE MOUTH WHILE USING THE BREATHE PILLOWS ENTRAINMENT INTERFACE, BREATHS ARE TOO SHALLOW TO TRIGGER VENTILATION; CHANGE THE TRIGGER SENSITIVITY TO A LOWER SETTING (HIGHER SENSITIVITY), ENSURE THE PATIENT INTERFACE IS NOT LEAKING AT THE PATIENT SIDE, ENSURE THE INTERFACE TUBING IS NOT PINCHED, CRUSHED, BENT, OR KINKED, INSPECT AND CLEAN THE INTERFACE PER THE INSTRUCTIONS FOR CLEANING THE INTERFACE. THE EVENT OF OXYGEN DESATURATION TO THE LOW 80¿S ACCOMPANIED BY THE PATIENT BEING DISORIENTED IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED. DURING INSPECTION, A LOW BREATH RATE ALARM OCCURRED BASED ON THE PROGRAMMED BREATH RATE BY THE RESPIRATORY CLINICIAN WHEN SETTING A PATIENT UP ON THE DEVICE; HOWEVER, NO DEVICE MALFUNCTION WAS IDENTIFIED.
IT WAS REPORTED THAT ON SEVERAL OCCASIONS, THE PATIENT¿S OXYGEN TUBING DISCONNECTED FROM THE LIFE2000, AND THE DEVICE DID NOT ALARM. THE PATIENT IS A 77-YEAR-OLD MALE WITH A MEDICAL HISTORY OF COPD AND CHRONIC RESPIRATORY FAILURE, UNSPECIFIED WHETHER WITH HYPOXIA OR HYPERCAPNIA. PER THE PATIENT, THE REPORTED EVENT HAS OCCURRED WHEN THE PATIENT¿S WIFE ROLLED OVER THE TUBING WITH HER WHEELCHAIR, OR WHEN THE PATIENT WAS MOVING AROUND THE HOME. THE PATIENT DECLINED A TRAINER VISIT TO DETERMINE IF THE SET UP COULD BE REARRANGED IN THE HOME. PER THE PATIENT, THERE WAS NO WAY OF KNOWING WHEN THE OXYGEN TUBING BECAME DISCONNECTED UNTIL HE WAS SYMPTOMATIC/DISORIENTED WITH SPO2 INTO THE LOW 80¿S. ONCE THE PATIENT RECONNECTED THE OXYGEN TUBING TO THE LIFE2000 FROM HIS HOME OXYGEN CONCENTRATOR DELIVERING 3 LPM, HIS SPO2 RECOVERED TO BASELINE OF 96-97%. DUE TO THERE BEING NO ALARMS TO WARN OF THE DISCONNECTION BETWEEN THE LIFE2000 AND OXYGEN TUBING, THE PATIENT HAS REQUESTED TO RETURN THE DEVICE. THE PATIENT DID NOT HAVE TO SEEK MEDICAL ATTENTION FOR LOW SPO2 AS HE WAS ABLE TO QUICKLY RECOVER AT HOME. THE LIFE2000 VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. THE DEVICE INSTRUCTION FOR USE NOTE THE FOLLOWING WARNING: IF THE BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM IS NOT FUNCTIONING PROPERLY, RESPIRATORY THERAPY MAY BE COMPROMISED AND MAY RESULT IN PATIENT HARM OR DEATH. ALWAYS HAVE AN ALTERNATE MEANS OF VENTILATION OR OXYGEN THERAPY AVAILABLE. THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING REGARDING MONITORING FOR OXYGEN ADMINISTRATION: TO ENSURE ACCURACY OF OXYGEN ADMINISTRATION AND TO MONITOR FOR THE PRESENCE OF CONTAMINATION (INCORRECT GAS CONNECTED), USE AN EXTERNAL OXYGEN MONITOR TO VERIFY THE OXYGEN CONCENTRATION IN THE DELIVERED GAS. 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, THE CHANGE WAS TEMPORARY, AND THE PATIENT RECOVERED AT HOME BY RECONNECTING THE OXYGEN TUBING TO THE LIFE2000 FROM THE OXYGEN CONCENTRATOR DELIVERING THE PRESCRIBED OXYGEN THERAPY. HOWEVER, THE EVENT OF OXYGEN DESATURATION TO THE LOW 80¿S ACCOMPANIED BY THE PATIENT BEING DISORIENTED IS CONSIDERED LIFE-THREATENING, CONCLUDING A SERIOUS INJURY OCCURRED. THE ULTIMATE CAUSE OF THE REPORTED DROP IN OXYGEN SATURATION IS LIKELY MULTIFACTORIAL DUE TO THE PATIENT'S UNDERLYING PULMONARY PATHOLOGY AND OXYGEN TUBING DISCONNECTING FROM THE LIFE2000. ALTHOUGH THE PATIENT ALLEGED THE DEVICE DID NOT ALARM FOR THIS CONDITION, THE DEVICE IFU WARNS USERS TO USE AN EXTERNAL OXYGEN MONITOR TO ENSURE ACCURACY OF OXYGEN ADMINISTRATION. AT THIS TIME, A DEVICE INSPECTION IS PENDING, AND A MALFUNCTION CANNOT BE RULED OUT. THE COMPLAINT WILL BE REASSESSED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT ON SEVERAL OCCASIONS, THE PATIENT¿S OXYGEN TUBING DISCONNECTED FROM THE LIFE2000, AND THE DEVICE DID NOT ALARM. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
IT WAS REPORTED THAT ON SEVERAL OCCASIONS, THE PATIENT¿S OXYGEN TUBING DISCONNECTED FROM THE LIFE2000, AND THE DEVICE DID NOT ALARM. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35555 | LIFE2000 VENTILATOR PACKAGED | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | WELCH ALLYN INC | BT-20-0002 | 00887761978201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Other |