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

Model Number 00-3020

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Cardiac Arrest (1762)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It has been reported to philips that the monitor appeared to fail to deliver a shock.The patient showed no signs of the shock being delivered.The crew noted no noise was noted from the monitor and no movement from the patient.New pads were attempted with no change.The monitor was removed from service.The patient outcome is unknown.

• Brand Name: TEMPUS LS MAN DEFIBRILLATOR
• 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: dana tackett ; altgasse 68; baar 6341 ; SZ 6341 ; 0417664242
• MDR Report Key: 16725087
• MDR Text Key: 313143093
• Report Number: 3003832357-2023-00206
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/12/2023
• 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