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

Model Number 00-3020

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 04/23/2022

Event Type  Injury  

Manufacturer Narrative

A user report was received related to a reported patient harm which is currently being investigated.At the time of reporting, the device has not yet been returned for investigation.Further updates will be provided when the device is received and investigation has progressed.

Event Description

The customer described the problem as 'unable to pick up the leads'.Further details about the incident and details related patient harm is awaited from the customer.

Manufacturer Narrative

Philips received a complaint on the tempus ls indicating that the device did not recognize the leads.Case escalated to technical investigation.Investigation performed on log- and rescue-files by research & development department.The supported rescue-files and the full disclosure form showed the same data.During the whole intervention no pads where attached, expect at 13:29:30-13:29:23 (utc-4) (rescue-file 19:29:30-19:29:31 (utc+2)).In the rescue-file ecg lead ii was recorded from 19:30:22-19:32:52.In the full disclosure from tempus pro the same ecg was recorded (13:30:22-13:32:52).After this time both files do not show any ecg lead ii signals.On 14.04.2022 the device was only used in manual mode (4) and therefore the connected ecg on lead ii was never showed on the display, but it seems to be transmitted to the tempus pro (device of rdt philips).Based on the provided event description, it assumed that the hcp was expecting the tempus ls manual to display an ecg signal from the ecg leads.The ecg leads as per specification are only displayed in monitor or pacer mode.Based on these results, a use error can be assumed.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 investigation concludes that no further action is required at this time.If additional information is received, the complaint file will be reopened.

Manufacturer Narrative

Component code grid updated to reflect investigation previously reported on mfr#: 3003832357-2022-00004.

• 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: 14474028
• MDR Text Key: 296678855
• Report Number: 3003832357-2022-00004
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• 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
• Date Manufacturer Received: 11/21/2023
• 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): Other