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

Model Number 00-3020

Device Problems Therapeutic or Diagnostic Output Failure (3023); No Pacing (3268)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

Customer reported during a training session tempus ls was to be used to pace on a simulator and did not pace.Device displayed an error message as ¿hardware failure dpm.¿ 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.

Event Description

The customer reported during a training session tempus ls was to be used to pace on a simulator and did not pace.The device displayed an error message as ¿hardware failure dpm¿.The schiller the manufacturer investigated the complaint and analysed log and rescue file.

Manufacturer Narrative

Updated the report from serious injury to product problem in the type of reported complaint.

Manufacturer Narrative

Philips received a complaint on the 989706001681 (tempus ls man defibrillator) indicating that the device failed to pace during training and issued a "hardware failure dpm" error message.Remote support was provided, and found that the customer was unable to use their device.During a training session, the customer was attempting to use the device to pace on a simulator and the device would not pace.The equipment was removed from service and a replacement tempus ls was provided.The tempus ls manual defibrillator (sn: (b)(6) was returned to philips / original equipment manufacturer (oem), schiller, for additional analysis.The complaint was escalated for technical investigation and the results indicated that error 26 was confirmed on multiple dates.The device failed the initial incoming inspection.After the repair department tested the device again, the device passed all tests.Schiller the manufacturer determined the cause was an intermittent loss of communication due to hardware failure, suspecting a mechanical issue such as the connector between the dpm board and mainboard.Based on the information available and the testing conducted, the cause of the reported problem was a mechanical connection issue.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.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.

• 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: 15844095
• MDR Text Key: 304108023
• Report Number: 3003832357-2022-00052
• 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,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?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 10/24/2022; 10/24/2022
• Supplement Dates FDA Received: 07/21/2023; 08/23/2023; 03/28/2024
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other