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

Model Number 00-3020

Device Problem Mechanical Jam (2983)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

As described by the customer ' tempus ls-manual intermittently will not power on.Customer made sure the battery was firmly seated and is was firmly "clicked" in.After applying some additional pressure on battery the ls powered on.When pressure is released the ls will go back to intermittently not powering on'.This device malfunction was detected by the user on (b)(6) 2022 prior to clinical use with no patient involvement.Neither logfiles nor the device were available at that time.Therefore, no investigation could be performed and this case was classified as non-potential safety issue, as there are multiple possible root causes (including mechanical damage and use error) which was impossible to determine with the available information.The device received on 2022-06-10 for investigation by the manufacturer schiller.The investigation showed that the malfunction is due to a squeezed internal flat ribbon cable.The flat ribbon cable was squeezed during production.The proper connection of the flat ribbon cable is checked during the device test by checking the functionality of the buttons.This test is performed twice throughout the production process (tempus ls prüfanweisung 1.Test - tempus ls - schiller qms, version 25: chapter 6.3 (prior climatic test) and chapter 6.27.2 (post climatic test)) to reduce the possibility of undetected production failure (e.G.Damaged internal cables).However, in some rare cases this issue may stay undetected.In these cases the conducting path of the flat ribbon cable does not break immediately during the assembly but may break over time due to mechanical stress applied by internal parts which squeeze the flat ribbon cable.According to the fault tree analysis (anx corp risk estimation and acceptance criteria - corporate area - schiller qms, version 38) and the device's risk group (risk group 10), this failure leads to the hazardous situation "device unusable", which in worst case results to the harm "reduction of probability of survival" which is classified as severity level "s3".Based on the risk management plan a malfunction with severity "s3" in worst case: results or may result in permanent impairment or irreversible injury, or requires or may require immediate medical or surgical intervention to prevent permanent organ damage or reduces or may reduce the probability of survival, or results or may result in unnecessary or preventable surgical intervention.Therefore, this case is considered as reportable.Due to internal miscommunication at schiller this case was forwarded to vigilance only on 2022-07-12 which is why the reportability decision is delayed.

• 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: selvaganesan balu ; ascent 1, aerospace centre; aerospace boulevard; farnborough ; UK
• MDR Report Key: 15155918
• MDR Text Key: 303632438
• Report Number: 3003832357-2022-00018
• 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: K20849
• 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

• Date FDA Received: 08/03/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other