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

Model Number 99577

Device Problems Unable to Obtain Readings (1516); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2020

Event Type  malfunction  

Event Description

Lifepack monitor had an issue, the wrench icon lit up red and the monitor would not read the patient ekg on the 4-lead or the defib.Pads for approximately 5-minute period.New defib pads were switched out and the monitor was still not reading the ekg on 4-lead, or from defib.Pads.Defibrillation treatment during transport was not able to be performed during pulse checks due to this.The monitor also was unable to transmit after this.Previous, earlier in the shift the monitor was transmitting with no issues.

• Brand Name: LIFEPAK 15 MONITOR/DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 10991347
• MDR Text Key: 220990317
• Report Number: 10991347
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 99577
• Device Catalogue Number: 99577-001955
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2020
• Event Location: Other
• Date Report to Manufacturer: 12/11/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1