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

Model Number 00-3020

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/10/2022

Event Type  malfunction  

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 device dpm hardware failure occurred during pacing.The complaint was escalated for technical investigation and the results indicate that the pacer board was not glued ¿protection folio of the vhb facing the igbt module has not been removed before dpm assembly.It has been concluded that the failure is due to an production operator error.In order to avoid this kind of failure a verification process must be included once both boards have been assembled.The manufacturer is implementing manual verification of the mechanical maintaining of the pacer board (wsm0218a) after assembly of both boards (wsm0217a and wsm0218a).This will be added in an updated dpm assembly document : dmind 8188.The device moved to loaner pool after the dpm glued correctly.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: 17413225
• MDR Text Key: 319986572
• Report Number: 3003832357-2023-00495
• Device Sequence Number: 1
• Product Code: LDD
• 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

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
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other