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

Model Number 00-3020

Device Problems Failure to Deliver Energy (1211); Insufficient Information (3190); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Customer reported tempus ls device pacer was not working.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 the investigation is in progress.

Manufacturer Narrative

Based on the description provided by the customer, this device had some pacing issue.Neither the device nor the logfiles were provided by the customer.The investigations involved a "good faith effort" to obtain information and the device for the investigation.Despite all the efforts, schiller ag was not able to obtain the requested information and device.Therefore, neither investigation could be done nor root cause could be determined.Customer confirmed that the patient was not involved, issue occurred during pm.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

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 pacer is not working.

Manufacturer Narrative

Device problem code and method code updated.

Manufacturer Narrative

Correction: component code updated to insufficient information.Neither the device nor the log files were provided by the customer.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, neither investigation could be done nor root cause could be determined.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 pacer is not working.The customer confirmed that the patient was not involved, the issue occurred during preventive maintenance.

• 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: 15803660
• MDR Text Key: 303700670
• Report Number: 3003832357-2022-00050
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 10/19/2022; 10/19/2022; 10/19/2022
• Supplement Dates FDA Received: 02/21/2023; 02/06/2024; 04/12/2024
• 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): Other