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

Model Number 00-3020

Device Problems Circuit Failure (1089); Pacing Problem (1439); Appropriate Term/Code Not Available (3191)

Patient Problems Twitching (2172); Asystole (4442); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  Death  

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 while treating an urgent patient, we attempted to pace.Initially everything was working we achieved mechanical capture.About in a minute into pacing i noticed a change in the ecg pattern, a slow near asystole waveform, the pacer had stopped pacing and displayed an error message "edm equipment".The pacer would not allow us to even to begin electrical therapy again.We tried to trouble shoot the device by reapplying the leads and unplugging and plugging the wire back in with no change.Pt condition immediately deteriorated passed a point of no return.Once arrived on scene with his device we attached our wire to his and the pacer worked as intended without any therapeutic results (pt's arm was twitching with out a pulse) as the pt was now in asystole.

Event Description

The incident described as follows by the customer - while treating an urgent patient, we attempted to pace.Initially everything was working we achieved mechanical capture.About in a minute into pacing i noticed a change in the ecg pattern, a slow near asystole waveform, the pacer had stopped pacing and displayed an error message "edm equipment".The pacer would not allow us to even to begin electrical therapy again.We tried to trouble shoot the device by reapplying the leads and unplugging and plugging the wire back in with no change.Pt condition immediately deteriorated passed a point of no return.Once d51 arrived on scene with his device we attached our wire to his and the pacer worked as intended without any therapeutic results (pt's arm was twitching with out a pulse) as the pt was now in asytole.The customer received replacement device.The failure device has been sent to the manufacturer for investigation.The evaluation of the log files and the rescue files coincide and show the pacer error.This error could not be reproduced with this device afterwards.Therefore, it must be assumed that this error was an incorrect measurement of the control system.Note: crit error 26 pacer ¿ current measurement error, pulse duration error, overcurrent error, rate overrun error and overvoltage error.

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 the device failed to deliver therapy on patient.Patient passed away.Investigation on log data and functional test on the device concluded that the device has a non reproducible pacer issue - error 26.Cause: communication to dpm failed (pacemaker communication).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 investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: 12391005
• MDR Text Key: 268894301
• Report Number: 3003832357-2021-10002
• Device Sequence Number: 1
• Product Code: LDD
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/04/2021
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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