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

Model Number 00-3020

Device Problems Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

Biomed stated they were doing the pm on this unit and found it has a constant dpm error and didn't pace.A user report was received related to a reported product problem 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 the investigation is in progress.

Manufacturer Narrative

This report is based on information provided by a philips field service engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the 989706001681 (tempus ls man defibrillator) indicating that during preventative maintenance, the device had a constant dpm error message and will not pace.The complaint was escalated for technical investigation by the original equipment manufacturer, schiller.Schiller reviewed the device logs and no device malfunction was found on the reported event date.Several error 26 entries were logged on previous dates.Clarification on the event date was requested but additional information was not provided.The device return for failure analysis was requested but was not completed as the customer could not receive an exchange device as they did not have active warranty coverage.The malfunctioning device remains at the customer site.Therefore, the customer's complaint cannot be confirmed and the root cause cannot be determined.The information in the complaint investigation summary addresses the current investigation findings.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, the record will be reopened for reassessment.Based on the information available, the cause of the reported problem is unknown and the root cause cannot be determined without the return and evaluation of the device.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.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 engineer ordered a replacement tempus ls, however, the customer did not have warranty coverage and were ineligible for a device exchange.We are unable to confirm the final disposition of the malfunctioning device because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.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: 15885837
• MDR Text Key: 304518333
• Report Number: 3003832357-2022-00057
• 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

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 11/01/2022
• 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