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

Catalog Number 453564842181

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  Injury  

Event Description

It has been reported to philips that tempus ls - failed to show a rhythm for a pedi patient in cardiac arrest.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 completed.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the 989706001681 (tempus ls man defibrillator) indicating that the device failed to show a rhythm for a pediatric patient in cardiac arrest.The allegation reportedly occurred while in clinical use on a patient.The patient outcome is unknown, despite multiple attempts from the remote service engineer to obtain additional information regarding the patient and complaint.Available details indicate the patient was placed on both the tempus ls and tempus pro (reported under: (b)(4), and both devices failed to show the patient's rhythm.The remote service engineer made multiple attempts to request additional information regarding the patient and event, but the customer did not respond.A replacement tempus ls was provided to the customer.The tempus ls (sn: (b)(6) was returned to schiller, the original equipment manufacturer (oem) for additional analysis.The complaint was escalated for technical investigation and the results indicate the device was tested and no issues were found.The tempus ls housing and ecg cable connector were found to be broken.The device will be returned to philips as is, as the device cannot be repaired.The customer's complaint could not be confirmed.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.However, the ecg cable connector was found to be broken.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 customer was provided a replacement device to resolve the issue.The investigation identified [design issue, manufacturing issue, assembly issue, other] and further action has been initiated.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the 989706001681 (tempus ls man defibrillator) indicating that the device failed to show a rhythm for a pediatric patient in cardiac arrest.The allegation reportedly occurred while in clinical use on a patient.The patient outcome is unknown, despite multiple attempts from the rse to obtain additional information regarding the patient and complaint.Available details indicate the patient was placed on both the tempus ls and tempus pro (documented under: (b)(4), and both devices failed to show the patient's rhythm.The rse made multiple attempts to request additional information regarding the patient and event, but the customer did not respond.A replacement tempus ls was provided to the customer.The complaint was escalated for technical investigation and the results indicate the device was tested and no issues were found.The tempus ls housing and ecg cable connector were found to be broken.Photos have been uploaded to the attachments.The device will be returned to philips as is, as the device cannot be repaired.The customer's complaint could not be confirmed.The customer was provided a replacement device to resolve the issue.The investigation identified [design issue, manufacturing issue, assembly issue, other] and further action has been initiated.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: 16952443
• MDR Text Key: 315452663
• Report Number: 3003832357-2023-00316
• 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: 05/18/2023
• 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
• Date Manufacturer Received: 02/28/2024
• 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
• Patient Outcome(s): Other