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

Model Number 00-3020

Device Problems Communication or Transmission Problem (2896); Insufficient Information (3190)

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

Event Date 07/15/2022

Event Type  Injury  

Event Description

As described by the customer 'not seeing tracings when plugging in pads'.As per the complaint record 'there was a potential safety event happened' and the details are not described.Follow up in progress with customer to get the patient harm related details.The device return is anticipated for investigation.

Manufacturer Narrative

Schiller confirmed 3 intervention files from this date: on the first intervention file there was nothing connected, on the second after 9 min the defi pads have been connected with some disconnects later on, on the last file a defi shock has been provided.At no point an ecg was recorded via ecg cable/electrodes.The investigation involved a goo faith afford.Despite all efforts sag was not able to obtain information or the device.Therefore neither investigation could be done nor root cause be determined.Based on the evidence available the reported problem was unconfirmed.Despite all efforts (gfe), sag was not able to obtain requested information, including log and resque files.

Event Description

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 when pads applied to patient, ls reporting ¿check defibrillator electrodes¿ or no signal - ghosting of pads on patient.

• 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: rekha rv ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15223283
• MDR Text Key: 303630545
• Report Number: 3003832357-2022-00019
• 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

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: 453564842181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 07/19/2022
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other