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U.S. Department of Health and Human Services

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

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SCHILLER AG TEMPUS LS MAN DEFIBRILLATOR; LOW ENERGY DEFIBRILLATOR Back to Search Results
Model Number 00-3020
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It has been reported to philips the ls would not pick up or read any wave lengths on the 4 lead cables leaving the inability to pace.Swapped cables with a new set with no change in performance.
 
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Brand Name
TEMPUS LS MAN DEFIBRILLATOR
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
jon yard
ascent 1, aerospace centre
aerospace boulevard
farnborough GU14 -6XW
UK   GU14 6XW
MDR Report Key17261674
MDR Text Key318502626
Report Number3003832357-2023-00441
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 Health Professional
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number00-3020
Device Catalogue Number453564842181
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/14/2023
Initial Date FDA Received07/05/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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