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

Model Number 00-3020

Device Problems No Display/Image (1183); Communication or Transmission Problem (2896)

Patient Problems Unspecified Heart Problem (4454); Insufficient Information (4580)

Event Date 08/08/2022

Event Type  Death  

Event Description

As described by the customer 'unit failed to display during patient care' during evaluation stage, customer confirmed death of patient.Unit would not display ecg waveforms during patient monitoring.Philips rdt planning to receive the device for the investigation.

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 device failed to display ecg waveforms during patient care.The complaint was escalated for technical investigation.The investigations involved a "good faith effort" to obtain information and the device for the investigation.Despite all the efforts, schiller the manufacturer was not able to obtain the requested information and device.Therefore, neither investigation could be done nor root cause could be determined.The device was replaced for the customer.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.He investigation concludes that no further action is required at this time.

• 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: jon yard ; ascent 1, aerospace centre; aerospace boulevard; farnborough GU14 -6XW ; UK GU14 6XW
• MDR Report Key: 15360799
• MDR Text Key: 299270214
• Report Number: 3003832357-2022-00025
• 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: 989706001681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Death