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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS - MANUAL; LOW ENERGY DEFIBRILLATOR
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SCHILLER AG TEMPUS LS - MANUAL; LOW ENERGY DEFIBRILLATOR Back to Search Results
Model Number 00-3020
Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); No Device Output (1435)
Patient Problems Unspecified Heart Problem (4454); Insufficient Information (4580)
Event Date 10/15/2021
Event Type  Death  
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
Conclusion code grid and evaluation method grid updated to reflect investigation as reported with mfr report number#: 3003832357-2021-10005.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand Name
TEMPUS LS - MANUAL
Type of Device
LOW ENERGY DEFIBRILLATOR
Manufacturer (Section D)
SCHILLER AG
altgasse 68
baar 6341
SZ  6341
Manufacturer (Section G)
SCHILLER AG
altgasse 68
baar 6341
SZ   6341
Manufacturer Contact
tanya deschmidt
ascent 1, aerospace centre
aerospace boulevard
farnborough GU14 -6XW
UK   GU14 6XW
MDR Report Key12923678
MDR Text Key281662087
Report Number3003832357-2021-10005
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number00-3020
Device Catalogue Number89706001681
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age62 YR
Patient SexMale
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