MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,TR,VR,BT,V4; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Arrhythmia (1721)

Event Date 02/18/2021

Event Type  Death  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.The customer indicated that the device will not be returned and will remain in service.The customer provided device data for evaluation and review.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.

Event Description

The customer contacted physio-control to report that their device reached a no shock advised decision when the patient was in a shockable rhythm.In this state the user may not be advised to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.

Event Description

The customer contacted physio-control to report that their device reached a no shock advised decision when the patient was in a shockable rhythm.In this state the user may not be advised to deliver defibrillation therapy if needed.This issue is patient related the customer indicated the device use may have contributed to a serious injury or death.

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.The customer indicated the device use may have contributed to a serious injury or death and provided physio-control with the available patient data.

Event Description

The customer contacted physio-control to report that their device reached a no shock advised decision when the patient was in a shockable rhythm.In this state the user may not be advised to deliver defibrillation therapy if needed.This issue is patient related the customer indicated the device use may have contributed to a serious injury or death.

Manufacturer Narrative

The device was not returned and no device evaluation was performed.The device data was available for review and physio control determined although the shock advisory algorithm has high sensitivity for vt, occasionally, the patient¿s ecg rhythm falls outside of the algorithm¿s ability to determine a ¿shock advised¿ decision due to the measurements falling near the threshold between a shockable and nonshockable rhythm.No device malfunction is suspected, the device operated as intended.

• Brand Name: LP15,EN,SPO2COMET,3L/12L,EX,NIBP,CO2,TR,VR,BT,V4
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 11500037
• MDR Text Key: 240381639
• Report Number: 0003015876-2021-00588
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873877081
• UDI-Public: 00883873877081
• Combination Product (y/n): N
• PMA/PMN Number: P160026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-001588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death