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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS; LOW ENERGY DEFIBRILLATOR

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SCHILLER AG TEMPUS LS; LOW ENERGY DEFIBRILLATOR Back to Search Results
Model Number 00-3020
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problem Cardiac Arrest (1762)
Event Date 05/17/2023
Event Type  Death  
Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
 
Event Description
It was reported the crew responded to cardiac arrest on (b)(6) 2023.When the crew opened the pads, all the gel was in the bottom corner of the pad(s) and three-fourths of it had no gel.This was corrected with another set of pads.The patient was asystolic (flat line) on ems arrival, therefore no attempt at any type of energy delivery occurred.The patient died.
 
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Brand Name
TEMPUS LS
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 Key17186713
MDR Text Key317718778
Report Number3003832357-2023-00404
Device Sequence Number1
Product Code LDD
UDI-Device Identifier07613365002737
UDI-Public07613365002737
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 Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00-3020
Device Catalogue Number989706001681
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2023
Initial Date FDA Received06/22/2023
Supplement Dates Manufacturer Received10/01/2023
Supplement Dates FDA Received02/23/2024
Was Device Evaluated by Manufacturer? No
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 Age94 YR
Patient SexFemale
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