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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 Computer Software Problem (1112); Display or Visual Feedback Problem (1184); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Event Description
As described by the customer 'tempus ls - connected to a patient and the screen went green.Device removed from service and another unit was used to monitor patient.Philips rdt planning to receive the device and send to the manufacturer for the root cause investigation.
 
Manufacturer Narrative
Based on the evidence available the reported problem was unconfirmed.The logfiles were requested on 2022-06-01.The files have not been provided until today.Therefore, no investigation could be performed, yet.Schiller manufacturer requested the logfiles and the return of the device from rdt 4 times: 2022-06-01 2022-06-09 2022-07-11 2022-08-08 the investigations involved a "good faith effort" to obtain information and the device for the investigation.Despite all the efforts, schiller was not able to obtain the requested information and device.Therefore, no investigation could be done.
 
Event Description
This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device screen went green whilst connected to a patient.The device was removed from service and another unit was used to monitor the patient.
 
Event Description
This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device screen went green whilst connected to a patient.
 
Manufacturer Narrative
Updated the evaluation method code grid originally provided on mfr # 3003832357-2022-00012.
 
Manufacturer Narrative
This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that device screen went green whilst connected to a patient.Device removed from service and another unit was used to monitor patient.Customer was asked for rescue files, log files and additional information regarding the circumstances and pt outcome.Rescue files received and information.The device was attached to a patient inside of a skilled nursing facility due to altered mental status.After moving to the medical unit they were placed on the tempus monitor which showed a normal sinus rhythm, (the crew then assumed that the patient's altered mental status was not attributed to a cardiac issue) the ls seemed to "correct itself" just prior to arriving at the ed (the crew left the ls attached during transport).After the call tempus ls have been tested (by placing on an employee) and it seemed to function without issue.The device was requested the device to be sent to the manufacturer for analysis.The repair team tested the unit and no problems have been observed with the device except for the slightly damaged housing.The logs were analyzed by r&d software engineer and no sign of malfunction was observed.The rescue files are from 2022-05-15 ( the date in the report is 2022-05-19).At the date the event took place (according to the customer) there was no sign of electrodes being connected to the device.On 2022-05-15 the electrodes are connected only 3 times for a very short period of less than a second.The investigator suspects that, what was observed by the customer, was the one of the display pins for displaying green color has possibly got a loose connection.The device was inspected and the pings were reported to be working.The log files do not show any abnormal behaviour.Based on the evidence available the reported problem was unconfirmed.Rescue files shows no defibrillation pads or ecg cable have been attached during this intervention.A review of the risk management file was performed by the equipment manufacturer, schiller.Tempus ls risk analysis- schiller qms, version 23 and tempus ls risk management plan - tempus ls - schiller qms, version 13 were referred to when the decision was made to make the event not reportable.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The customer was provided a replacement device to resolve the issue.The alleged `faulty` device placed into the loaner pool.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
 
Event Description
This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device screen went green whilst connected to a patient.
 
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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 Key14852942
MDR Text Key303247674
Report Number3003832357-2022-00012
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 Received06/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00-3020
Device Catalogue Number989706001681
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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) Other;
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