MAUDE Adverse Event Report: SCHILLER AG TEMPUS LS - MANUAL; DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)

Model Number 3.940589

Device Problem Intermittent Continuity (1121)

Patient Problem Death (1802)

Event Date 12/30/2020

Event Type  Death  

Manufacturer Narrative

The user facility identified that the device had been dropped, which caused damage to the ecg defibrillation electrode cable and ecg connector on the device.The ecg cables involved were not made available for further assessment.The device logs were provided and reviewed.The evaluation showed the recording of the ecg signal was repeatedly interrupted by electrode loose messages.Ecg signal acquisition issues were attributed to a mechanical problem with defibrillation electrodes.The investigation attributed the incident to damage caused by dropping of the device during patient handling.

Event Description

The tempus ls-manual was used on a apnoeic, pulseless non-moving patient.The customer advised that the pads were plugged into the device which displayed 'check defibrillator electrodes'.At some point during movement of the patient, the crew noticed the electrode cable for the device was disconnected and on inspection noticed the plug in portion of the cable was broken and a piece remains stuck inside the device.The customer has advised that the tempus ls-manual was dropped during the patient transport.The unit was checked back at base by senior facility staff and the identified issue could not be replicated.

• Brand Name: TEMPUS LS - MANUAL
• Type of Device: DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
• Manufacturer (Section D): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer (Section G): SCHILLER AG; altgasse 68; baar 6341 ; SZ 6341
• Manufacturer Contact: tim bubb ; c2, ashwood park, ashwood way; basingstoke RG23 -8BG ; UK RG23 8BG ; 1256362400
• MDR Report Key: 11330338
• MDR Text Key: 231934321
• Report Number: 3003832357-2021-00002
• 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

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: 3.940589
• Device Catalogue Number: 00-3020
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/30/2020
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death