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

Model Number 00-3020

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2022

Event Type  Injury  

Event Description

The customer reports tempus ls - "failure to shock." "ls failed to shock patient in v-fib." 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.

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 failed to shock patient in v-fib.The investigation on the logfile confirmed the reported behavior.It showed that the internal safety discharges were caused by high impedance.As subsequent shocks could be delivered, sag concludes that the device did not malfunction at any time of the intervention, but detected the high impedance correctly.The root cause may be due to use error, faulty pads or due to patient's condition.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.

Manufacturer Narrative

The complaint was escalated for technical investigation, the log files were requested and then analyzed by schiller.The investigation on the logfile confirmed the reported behavior.It was observed that the internal safety discharges were caused by high impedance.As subsequent shocks could be delivered, sag concludes that the device did not malfunction at any time of the intervention, but detected the high impedance correctly.The root cause may be due to use error, faulty pads or due to patient's condition.Rdt investigation: log and rescue files were analysed for event date 06-dec-2022, the user description of event was seen.Log files indicate fist 7 successful shock deliveries, also indicate pads disconnection & connection by user (user changed the position of pads to anterior/posterior placement as per user statement).When the user changed the placement of pads no stable impedance was observed, the impedance fluctuated between approx.200ohm and 455ohm.The log files also indicate cpr compressions were performed continuously throughout the intervention.Subsequent 11 more shocks can also be seen in the log files as per user statement.Tempus ls does not recognise pads when the impedance measurement is out of range (less than 25o and or greater than 250o).It can be assumed that the pads were not attached firmly to patient body or pads had come loose when cpr compressions were being performed continuously, which did not allow the user to shock the patient on 8th time.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 16111806
• MDR Text Key: 306833816
• Report Number: 3003832357-2023-00006
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 11/29/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male