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

Model Number CRPLUS

Device Problems Invalid Sensing (2293); Device Sensing Problem (2917)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control determined that the cause of the reported issue was that a capacitor, designator c178, on the analog pcb assembly had process residue.The process residue made the voltages for legs 5, 6, and 7 of an integrated circuit (ic), designator u15, to not be the correct voltage values which kept the ecg waveform at a flat line.The customer was provided with a replacement device.

Event Description

The customer contacted physio-control to report that their device had a service wrench present on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order to charge and shock, if it were necessary.

Manufacturer Narrative

Section d4 of the initial medwatch report indicates: device identifier (di) number ¿ blank section d4 of the initial medwatch report should indicate: device identifier (di) number ¿ (b)(4).

Event Description

The customer contacted physio-control to report that their device had a service wrench present on the readiness display.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio observed that no matter what ecg waveform was input into it, the device would only read the waveform as a flat line.As a result, the device would not be able to detect a shockable ecg waveform in order to charge and shock, if it were necessary.

• Brand Name: LIFEPAK CR(R) PLUS DEFIBRILLATOR
• 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: 7400259
• MDR Text Key: 104820418
• Report Number: 0003015876-2018-00552
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00885074440330
• UDI-Public: 00885074440330
• Combination Product (y/n): N
• PMA/PMN Number: K033275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CRPLUS
• Device Catalogue Number: 99403-000157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1