MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 15

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Ventricular Fibrillation (2130)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.

Event Description

A customer contacted physio-control to report that their device was used to provide a synchronized shock to a patient during a cardioversion procedure. After the delivery of the synchronized shock, the patient's rhythm converted from stable ventricular tachycardia to ventricular fibrillation. The customer advised that the sense markers did not appear regularly on each qrs complex, and medical personnel were concerned that the patient had received a shock on the t-wave. Physio-control contacted the customer in order to obtain additional information about the patient, including the patient outcome; however, no response has been received.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• 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: 9234673
• MDR Text Key: 163640120
• Report Number: 0003015876-2019-01743
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K142430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 15
• Device Catalogue Number: 99577-000657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/24/2019 Patient Sequence Number: 1