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

Catalog Number 453564842181

Device Problems Protective Measures Problem (3015); Insufficient Information (3190)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that tempus ls the device was restricted because it failed the pm test.

Manufacturer Narrative

This report is based on information provided by philips repair service personnel and has been investigated by schiller and the he philips complaint handling team.Philips received a complaint on the tempus ls indicating that unit failed during preventive maintenance.The complaint was escalated for technical investigation and the results indicate that the issue is most likely due to an intermittent loss of communication between the dpm-board and the mainboard.As the issue is not clearly reproducible, the exact root cause cannot be determined.However, taking all components into account which are part of the communication path between the dpm-board and the mainboard, which may cause an intermittent loss of communication, the source of the issue is most likely to be of a mechanical nature such as a connector.Therefore, it is suspected that the board-to-board connector between the dpm-board and the mainboard may be the root cause for this issue.As the root cause cannot be verified, schiller the manufacturer cannot come to a conclusion.The customer received device replacement.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.

• 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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 16443049
• MDR Text Key: 310247447
• Report Number: 3003832357-2023-00049
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2023
• 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