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

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 06/03/2023

Event Type  malfunction  

Event Description

The patient went into a-fib with rvr and invasive arterial pressure immediately dropped.The defibrillator was charged to 200j synchronized and i witnessed the other nurse press the shock button and there was no shock delivered twice.I pressed the shock button also and the machine did not defibrillate.I disarmed the charge and had to recharge back to 200j and at this point the patient was in v-tach.The defibrillator discharged a shock properly that time. .

• Brand Name: LIFEPAK 20
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd., n.e.; redmond WA 98052
• MDR Report Key: 17669546
• MDR Text Key: 322488976
• Report Number: 17669546
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2023,06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2023
• Date Report to Manufacturer: 09/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA