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

Model Number 00-3020

Device Problem Unable to Obtain Readings (1516)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported there was an ecg malfunction.There was no patient involvement.

Manufacturer Narrative

The event date has been updated from 02aug2023 to 17jul2023.A replacement device was sent to the customer.The log and rescue files and the device were received at schiller where a technical investigation was completed.On inspection of the device at the ecg connection side deformation around the ecg port on the upper part was observed and other deformation towards the center of the ecg connector causing a poor ecg plug connection.Based on the damages observed schiller concluded that the most likely cause was that the device had been dropped on the side of the ecg connector.The device was tested satisfactorily with exception to the ecg port damage.The logs were analysed.A discrepancy was observed regarding the event date.Schiller identified a self test only, on the (b)(6) 2023 however the device was used on (b)(6) 2023 where pacing was completed and the logs suggest an interruption due to the device being potentially dropped.The returned device was removed from service and processed following local procedures.Based on the information available and testing conducted, the cause of the reported problem was most likely damaged ecg port casing however due to the discrepancy with the event date and that the findings are not the actual cause only most likely cause this investigation is concluded to be cause not established.The reported problem was not confirmed.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.

Event Description

It was reported there was an ecg malfunction.It was initially reported there was no patient involvement.This report has been updated to device use at the time of event was 'in use' although no patient or user harm or impact.

• Brand Name: TEMPUS LS
• 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: 17638497
• MDR Text Key: 322199897
• Report Number: 3003832357-2023-00569
• 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 Health Care Professional
• 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?: 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?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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