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

Catalog Number 453564842181

Device Problems Loose or Intermittent Connection (1371); Misconnection (1399)

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

Event Date 01/03/2023

Event Type  Injury  

Event Description

The customer reported tempus ls - due to connection issues, defibrillation was delayed.Ls log shows pads on/pads off several times before defibrillation was done.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 in progress.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer and schiller investigation team and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus ls indicating that due to connection issues, defibration was delayed.Ls log shows pads on/pads off several times before defibration was done.The complaint was escalated for technical investigation and the device was tested and was found to be working fine.The team commented, that there might have been something loose on the defibrillator pads or the way they were placed.Findings from r&d are as follows: all other connections in the signal path are reliable.When a simulator is connected, this behaviour is not occurring.So it is related to the cable and the attachments of the pads in particular.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 device was confirmed to be operating per specifications and no failure was identified.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: 16271115
• MDR Text Key: 308453212
• Report Number: 3003832357-2023-00023
• 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

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 Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 01/03/2023
• Supplement Dates FDA Received: 09/05/2023
• 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