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

Model Number 00-3020

Device Problems Computer Software Problem (1112); Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

As described by the customer 'failed to display ecg during simulation.Philips rdt planning to receive the device and send to the manufacturer for the root cause 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 ls indicating the unit failed to display ecg.It was being used on a patient during event but did not harm the patient.The complaint was escalated for technical investigation and ecg socket loose has been noted.The engineer initiated pacer function several times at 180/min, 200ma, and no errors occurred.An error message corresponding to the description has been found in the log files.Despite this error message, the pacer was started 108 seconds after the device was started.The pacer was then started.It paced at a rate of 70/min.First with 70 ma, then with 90 ma and with 100 ma.1510 seconds after device start, pacing was terminated and the device switched off.Therefore, it may be assumed that the device was working as intended.The schiller states the error message occurs when the ecg ad converter cannot be configured correctly after several attempts.If this occurs, an ecg may not be read.Based on the information available and the testing conducted, the reported problem was unconfirmed.A review of the risk management file was performed, and the potential severity is s3 has been identified in the risk document.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.It has been concluded 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: 14868936
• MDR Text Key: 302960906
• Report Number: 3003832357-2022-00014
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 07613365002737
• UDI-Public: 07613365002737
• 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: 06/30/2022
• 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
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2021
• 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