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

Model Number 00-3020

Device Problems Loose or Intermittent Connection (1371); Device Sensing Problem (2917)

Patient Problem Cardiac Arrest (1762)

Event Date 01/06/2023

Event Type  Death  

Event Description

It was reported to philips that the device tempus ls review shows pads attached / pads detached rapidly in a repeating pattern when in use.The patient was pronounced in the emergency room.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.

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 indicating that there is an error in reading pads (therapy pads).The cardiac arrest was witnessed, and the patient was pronounced dead in the emergency department.Review shows that the pads were attached and detached rapidly in a repeating pattern when in use.Customer confirmed that the problem was with the tempus ls itself, and not the pads.The user explained that they swapped pads and concluded that the ls was the problem, not the pads.The complaint was escalated for technical investigation.Schiller investigated the complaint and following observations were made, 1) on (b)(6) 2022, a lot of electrodes connected/disconnected are found from log files after 50 minutes of start of rescue intervention, lasting for 9 minutes before electrodes removed & the device shutdown.These events follow at very irregular intervals.It is noticeable that the time between disconnect and connect is smaller than the time between connect and disconnect.So the electrode-off time is short, i.E.Mostly about 1 second.This indicates a loose contact due to insufficiently glued pads.2) besides the loose contact of pads, it is noticeable from log files that the ecg front-end had to be reinitialized very often because of too many detected pacemaker pulses, meaning cpr was done for 50 minutes from the beginning.The pads could be very well ruined after 50 minutes of cpr.3) minor electrical noise was observed between the signals of defib ecg and electrode ecg.They seem to have influenced each other.There is no clean signal on both defib ecg and electrode ecg that indicates a problem affecting both modules.However, the noise in signals is within the normal parameters.Rdt investigation: log and rescue files (on (b)(6) 2022) show stable impedance of 132 o, which is in the acceptable range (25o-250o).Hence there is no problem with impedance measured by pads.It is not possible to determine the definite root cause since the hairiness(thicker lines of signals due to electrical noise) of the signal is acceptable, the device passed functional testing and the incoming inspection.The most likely cause of the problem could be due to ruined pads after a 50 minutes cpr.Schiller confirmed that the impedance values were checked on their inspections test and the device passed on the functional tests.The reported event of death was reviewed by pms clinical expert.This event is assessed as possibly related to the product problem with the device where pads detach rapidly in repeating pattern.This event is assessed at a severity 4 (death) and this is higher than predicted in the rmf tlsra version 17, tag line 419 and predicted severity3 (reduction in probability of survival.A review of the risk management file was performed by the equipment manufacturer, schiller.Tempus ls risk analysis- schiller qms, version 18/27 and tempus ls risk management plan - tempus ls - schiller qms, version 13 were referred to when the decision was made to make the event 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.If additional information is received the complaint file will be reopened.

Event Description

It was reported to philips that the pad connection reading error.

• 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 Key: 16386690
• MDR Text Key: 309664849
• Report Number: 3003832357-2023-00044
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 7613365002737
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• 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 Number: 1
• Patient Outcome(s): Death