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

Catalog Number 453564842181

Device Problems Use of Incorrect Control/Treatment Settings (1126); Unable to Obtain Readings (1516)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  Injury  

Event Description

It was reported to philips that during patient care, cardioversion was performed 6 times on a patient in v-tach with a pulse.Cardioversion #1 and # 6 were documented in corsium as synced.However, #2-#5 were not.The sync button was pushed each time, and the screen displayed the dots above the qrs, indicating that sync mode was turned on.Providing non-synced cardioversion was a critical failure.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is in progress.

Manufacturer Narrative

This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that the device is providing non-synced cardioversion.The complaint was escalated for technical investigation and the results indicate that the device was working as intended.The device was set to display the soft-key ¿sync¿, auto sync was disabled, which means the device will always start with async mode, and the device was set to disable the sync mode after async defibrillation shock is delivered, means the sync mode will reset to async mode after a sync shock delivering.It seems to be a case of lack of user awareness on device settings.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: 16349714
• MDR Text Key: 309260822
• Report Number: 3003832357-2023-00040
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 07/17/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other