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

Model Number 00-1024-R

Device Problems Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516)

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

Event Date 02/07/2023

Event Type  malfunction  

Event Description

It was reported to philips that ecg disabled on the screen system was just received from bench repair.A user report was received related to a reported product problem which is currently being investigated.Further updates will be provided when the investigation is completed.

• 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: 16495829
• MDR Text Key: 310879104
• Report Number: 3003832357-2023-00068
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 05060472441027
• UDI-Public: 05060472441027
• 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: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1024-R
• Device Catalogue Number: 989706000051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2023
• 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