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

Model Number 00-3020

Device Problems Device Sensing Problem (2917); Incomplete or Inadequate Connection (4037)

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

Event Type  Injury  

Event Description

It has been reported to philips the ls failed to read therapy pads when placed on patient.

Manufacturer Narrative

Type of reported complaint -changed to serious injury and adverse event.

Manufacturer Narrative

This report is based on information provided by philips repair service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the tempus pro indicating that the device failed to read therapy pads when placed on patient.The complaint was escalated for technical investigation and the results indicate that there is no abnormal behaviour in the log regarding the device's function.It may be assumed that the device works well when it is connected to a simulator.Rdt has tested the device and they could not identify any malfunction.Therefore, it may be assumed that the unit worked as intended.No malfunction of the device has been detected, device worked as intended.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 operational after repairs were completed.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

Updated investigation summary: 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 the device failed to read therapy pads when placed on patient.Patient in cardiac arrest.Patient outcome, delivered to ed with pulses.The complaint was escalated for technical investigation, the logs sent to schiller, and the results indicate that there is no abnormal behavior in the log regarding the device's function.The suspicion is that the pads might have not been attached properly.Rdt investigation: log and rescue files(dated (b)(6) 2023) analyzed and measured impedance values were varying very often, varying from too low(less than 25o) to too high (greater than 250 o) and finally stabilized at 110o.Initial variation of impedance values beyond acceptance range resulted in "check defib electrodes" message.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 ; 0417664242
• MDR Report Key: 16597385
• MDR Text Key: 311853582
• Report Number: 3003832357-2023-00132
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-3020
• Device Catalogue Number: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• 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