TEMPUS LS - MANUAL
Report
- Report Number
- 3003832357-2021-10005
- Event Type
- Death
- Date Received
- December 3, 2021
- Date of Event
- October 15, 2021
- Manufacturer
- SCHILLER AG
- Product Code
- LDD
- UDI-DI
- 07613365002737
- PMA / PMN Number
- K200849
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A USER REPORT WAS RECEIVED RELATED TO A REPORTED PATIENT DEATH WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED AND INVESTIGATION HAS PROGRESSED.
CONCLUSION CODE GRID AND EVALUATION METHOD GRID UPDATED TO REFLECT INVESTIGATION AS REPORTED WITH MFR REPORT NUMBER#: 3003832357-2021-10005.
CONTACT INFORMATION , DEVICE PROBLEM CODE GRID, PATIENT OUTCOME CODE AND CONCLUSION CODE GRID TO REFLECT INVESTIGATION AS REPORTED WITH MFR REPORT NUMBER#: 3003832357-2021-10005.
THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS (B)(6) YEARS OLD MALE (DOB: (B)(6)) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT HOSPITAL.
THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 62 YEARS OLD MALE (DOB: (B)(6) 1959) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT HOSPITAL. THE DEVICE HAS BEEN INVESTIGATED BY THE MANUFACTURER SCHILLER. BASED ON THE DEVICE TESTING AND INVESTIGATION PERFORMED ON THE DEVICE, NO DEVICE MALFUNCTION COULD BE FOUND. AS IT CAN BE PROVED THAT THE DEVICE DOES NOT MALFUNCTION, THE DEVICE WORKED AS INTENDED DURING THE INTERVENTION AND THE DISCONNECTS ARE CAUSED EITHER BY THE ACCESSORIES (DEFIB PADS) OR DUE TO PATIENT'S CONDITION. THEREFORE, THIS CASE IS CONSIDERED AS NOT REPORTABLE.
THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 62 YEARS OLD MALE (DOB: ON (B)(6) 1959) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT HOSPITAL. THE DEVICE HAS BEEN INVESTIGATED BY THE MANUFACTURER SCHILLER. BASED ON THE DEVICE TESTING AND INVESTIGATION PERFORMED ON THE DEVICE, NO DEVICE MALFUNCTION COULD BE FOUND. AS IT CAN BE PROVED THAT THE DEVICE DOES NOT MALFUNCTION, THE DEVICE WORKED AS INTENDED DURING THE INTERVENTION AND THE DISCONNECTS ARE CAUSED EITHER BY THE ACCESSORIES (DEFIB PADS) OR DUE TO PATIENT'S CONDITION. THEREFORE, THIS CASE IS CONSIDERED AS NOT REPORTABLE.
THE INCIDENT DESCRIBED AS FOLLOWS BY THE CUSTOMER - PATIENT WAS 62 YEARS OLD MALE (DOB: ON (B)(6) 1959) ASYSTOLE ON ARRIVAL. ADULT PADS WERE USED AND WOULD WORK FOR 25-30 SEC AND THEN ECG TRACING WOULD DISAPPEAR, AND WORK FOR 25-30 SEC. ¿CHANGED PADS AND THEY WORKED FINE REST OF CALL¿ PATIENT PRONOUNCED DEAD AT HOSPITAL. THE DEVICE HAS BEEN INVESTIGATED BY THE MANUFACTURER SCHILLER. BASED ON THE DEVICE TESTING AND INVESTIGATION PERFORMED ON THE DEVICE, NO DEVICE MALFUNCTION COULD BE FOUND. AS IT CAN BE PROVED THAT THE DEVICE DOES NOT MALFUNCTION, THE DEVICE WORKED AS INTENDED DURING THE INTERVENTION AND THE DISCONNECTS ARE CAUSED EITHER BY THE ACCESSORIES (DEFIB PADS) OR DUE TO PATIENT'S CONDITION. THEREFORE, THIS CASE IS CONSIDERED AS NOT REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1826927 | TEMPUS LS - MANUAL | LOW ENERGY DEFIBRILLATOR | LDD | SCHILLER AG | 00-3020 | 07613365002737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Death |