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

Model Number 00-3020

Device Problems Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

As described by philips distributor 'dpm hardware failure while pacing patient on june 27th, tech used medical therapy to treat the patient'.A user report was received related to a reported product problem 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

As described by philips distributor 'dpm hardware failure while pacing patient on (b)(6) 2023, tech used medical therapy to treat the patient'.A user report was received related to a reported product problem 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.Based on the investigation of the logfile by the manufacturer schiller, this error is caused due to communication error from the main board to the dpm module.However, the actual root cause cannot be concluded at this stage.The root cause shall be determined after the device was investigated.

Manufacturer Narrative

H3 other text : log files reviewed and device return anticipated.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer and schiller investigation team has been investigated.The philips complaint handling team received a complaint on the tempus ls indicating dpm hardware failure while pacing patient.The schiller manufacturer investigated the complaint with the log files provided and confirmed no error was found for 2022-06-27.Pacer mode was entered but the current was not increased above 0 ma thus no pace impulses have been delivered.Based on the investigation of the logfile "error 26" happened on 2022-08-24.This error could have caused due to communication error from the main board to the dpm module.However, the actual root cause cannot be concluded at this stage.The root cause shall be determined after the device was investigated at schiller.Customer unable to use pacing function from ls and patient was administered atropine which improved cardiac function but could have resulted in poor outcome due to patient already having a sick heart.The patient was transported to er with notification call made and vitals and procedures performed enroute with positive status change.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.

• Brand Name: TEMPUS LS-MANUAL
• Type of Device: LOW ENERGY DEBFIBRILLATOR
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15409125
• MDR Text Key: 299769960
• Report Number: 3003832357-2022-00027
• 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,Followup

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: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 08/24/2022
• Supplement Dates FDA Received: 09/29/2022; 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR