MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number CR2

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to physio-control for evaluation.Based on the reported information, physio has determined that the likely cause of the reported issue was the lid assembly, which resulted in the missing magnet.The customer has been provided with a replacement lid.

Event Description

The customer contacted physio-control to report that their device was missing the magnetic pin the lid.In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.

Manufacturer Narrative

The reported issue was confirmed.An engineering investigation has determined that due to the design of the lcpr2 lid switch, absence of the lid magnet allows current to flow from the battery, even when the device is in standby mode.This will reduce the life of the battery.Therefore, the reported issue, the loss of lid/lid magnet, is associated with two hazardous situations: opening the lid does not turn on the device, and, higher than intended current draw while the device is in standby mode results in a prematurely depleted the battery.Replacement of the device lid so that the magnet is present in the device allows the lid switch to function as designed; turning on/off the device when the lid is opened and preventing current draw when the device lid is closed.The lpcr2 operating instructions has been updated to include additional troubleshooting tips to direct the customer to act when device behavior indicates the lid magnet may be missing.A new warning informs the customer of the risk associated with a missing magnet.

Event Description

The customer contacted physio-control to report that their device was missing the magnetic pin the lid.In this state the device will not turn on automatically, which can lead to a use error resulting in a failure to deliver defibrillation.There was no patient use reported with the event.

• Brand Name: LIFEPAK CR2 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: 11017038
• MDR Text Key: 221800068
• Report Number: 0003015876-2020-01888
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00883873824139
• UDI-Public: 00883873824139
• Combination Product (y/n): N
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-001261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3015876-01/14/2021-001-C
• Patient Sequence Number: 1