MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 20

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control evaluated the customer's device and was unable to duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was subsequently returned to the customer for use.A physio clinical specialist performed a clinical review and determined that the device use contributed to the patient outcome due to user error.

Event Description

A customer contacted physio-control to report that they provided an unintentional shock to a patient instead of a synchronized (sync) shock, which converted the patient's heart rhythm into ventricular fibrillation.As a result, wrong defibrillation therapy was provided.The customer advised that a subsequent shock was provided, and converted the patient back to a normal sinus rhythm.

• Brand Name: LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 10428701
• MDR Text Key: 203717543
• Report Number: 0003015876-2020-01098
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K130454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20
• Device Catalogue Number: 99402-000010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2005
• 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): Life Threatening