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

Model Number 00-3020

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Insufficient Information (4580)

Event Date 12/30/2021

Event Type  Death  

Manufacturer Narrative

A user report was received related to a reported patient death 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 investigation has progressed.

Event Description

The complaint as described by the customer "the crew encountered a person in cardiac arrest and had difficulty getting the defibrillation electrodes to read a rhythm.The initial pads displayed a dashed line and the message ¿check electrodes¿.The crew removed the pads, which were reported to be well adhered, and re-prepared the skin.The crew then replaced the pads with a new set.The second set of pads also displayed the ¿check electrodes¿ message and a dashed line.The crew then placed the 3 lead monitoring electrodes to check the patient¿s rhythm and found the patient to be in asystole.Tempus pads lot y010521-04 it should be noted that the pads were disconnected from the initial ls and attached to another ls that was on scene (7022.00925) and they gave the same error message.Both tempus ls devices have subsequently worked normally with pads from a different lot number".

Manufacturer Narrative

H3 other text : log files investigation performed.

Event Description

The complaint as described by the customer "the crew encountered a person in cardiac arrest and had difficulty getting the defibrillation electrodes to read a rhythm.The initial pads displayed a dashed line and the message ¿check electrodes¿.The crew removed the pads, which were reported to be well adhered, and re-prepared the skin.The crew then replaced the pads with a new set.The second set of pads also displayed the ¿check electrodes¿ message and a dashed line.The crew then placed the 3 lead monitoring electrodes to check the patient¿s rhythm and found the patient to be in asystole.Tempus pads lot y010521-04 it should be noted that the pads were disconnected from the initial ls and attached to another ls that was on scene (7022.00925) and they gave the same error message.Both tempus ls devices have subsequently worked normally with pads from a different lot number".Log files have been sent to the manufacturer for investigation.From the log files investigation, it was found ¿defi electrodes disconnected event" which means that the pads have been disconnected.Therefore, the investigation outcome is that the issue was related to the pads.The tempus ls device itself worked correctly.The legal manufacturer of the pads is nissha and the legal manufacturer of the pads was informed about the latest complaints involving tempus ls pads, including this one (email by (b)(6)' on 08.03.2022).

• Brand Name: TEMPUS LS - MANUAL
• Type of Device: LOW ENERGY DEBFIBRILLATOR
• 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: 13453971
• MDR Text Key: 285149530
• Report Number: 3003832357-2022-00001
• 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
• Type of Report: Initial,Followup,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 Model Number: 00-3020
• Device Catalogue Number: 989706001681
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 01/07/2022; 01/07/2022
• Supplement Dates FDA Received: 04/22/2022; 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2021
• 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): Death