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

Model Number 00-3020

Device Problems Defibrillation/Stimulation Problem (1573); Insufficient Information (3190)

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

Event Date 02/06/2023

Event Type  Injury  

Event Description

It was reported to philips that the crew reported that the monitor showed that a shock was delivered however states that no signs of shock being delivered were noted.The patient did not "jump", no sound, and did not appear to actually provide the shock.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.

Manufacturer Narrative

Philips received a complaint on the tempus ls indicating that the monitor showed that a shock was delivered however states that no signs of shock being delivered were noted.The patient did not move and there were no characteristic sound, and the device did not appear to actually provide the shock.The event date: (b)(6) 2023.The customer cannot confirm the patient outcome as the patient was transported and turned over to the local hospital.The complaint was escalated for technical investigation and the results indicate that no errors were observed.Rear housing is damaged.30 shocks of differing energies were tested in rapid succession; all shocks were measured and were all within the 10% tolerance.Pacer was also left to run multiple times.No errors.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.

• 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: 16500934
• MDR Text Key: 310853512
• Report Number: 3003832357-2023-00072
• 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

• 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: 453564842181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 08/22/2023
• 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