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

Model Number CR2

Device Problems Failure to Power Up (1476); Detachment of Device or Device Component (2907)

Patient Problem Asystole (4442)

Event Date 07/21/2020

Event Type  Death  

Manufacturer Narrative

Physio control performed a clinical review of the event and determined that since the device was unable to be powered up and deployed for use there is no ecg data for the first 18 minutes of the patient¿s cardiac arrest.It is unknown if the patient was in a shockable rhythm and unknown if the device use caused or contributed to the patient¿s outcome.It was confirmed that when the device received a new battery, after the event, the status returned back to "ready".Physio control downloaded the electronic device records and it was decided to provide the customer with a replacement device, so the customer's device could be returned to physio control for further investigation.Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available. 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 would not power on when attempting to be used with a patient.The patient was found unconscious and not breathing by the rescue service.An ambulance arrived 18 minutes after the arrival of the rescue service and found a patient with asystole.The patient associated with the event did not survive.

Event Description

A customer contacted physio control to report that their device would not power on when attempting to be used with a patient.The patient was found unconscious and not breathing by the rescue service.An ambulance arrived 18 minutes after the arrival of the rescue service and found a patient with asystole.The patient associated with the event did not survive.

Manufacturer Narrative

Section h1 of supplemental medwatch report 001 indicates: malfunction.Section h1 of supplemental medwatch report 001 should indicate: death.

Event Description

A customer contacted physio control to report that their device would not power on when attempting to be used with a patient.The patient was found unconscious and not breathing by the rescue service.An ambulance arrived 18 minutes after the arrival of the rescue service and found a patient with asystole.The patient associated with the event did not survive.

Manufacturer Narrative

Stryker performed a review of the downloaded electronic device records, and found that the installed battery went to "replace" status on (b)(6) 2020.This caused the readiness of the device to change to "not ready - replace battery".The battery subsequently fell below the "shutdown" threshold on (b)(6) 2020.Contact with the customer revealed that there was no information a battery replacement was performed prior to the patient event, after the change in status on (b)(6) 2020.The battery was inserted into the device on (b)(6) 2019, and thus reached the "replace" threshold in less than 1 year.In further follow-up communication with the customer, it was confirmed that the device's lid was missing its magnet, prior to the patient event.In further review of the electronic records it was determined that the missing magnet had contributed to the battery depletion, due to an increase in current draw.Based on the lid lot code, it was determined, that the lid dimensions were out of specification, causing the lid magnet to be missing.Additionally, it was determined that the customer did not properly maintain the devices state of readiness, per the lpcr2 operating instructions, as the patient event occurred nearly 3 months after the device reached "not ready - replace battery" status.The operating instructions state: "device readiness should be verified at least once each month.If your device has wireless access to lifelinkcentral aed program manager or lifenet system, you can verify the device status remotely.If your device does not have wireless access, you must check the readiness indicator on the device." the cause of the reported issue, of the device not powering on, was determined to be due to a depleted battery.The missing lid magnet, caused by an out of specification lid, contributed to the battery depleting sooner than expected.Additionally, the customer not verifying the device's readiness between the change in readiness on (b)(6) 2020 and the patient event on (b)(6) 2020, led to the battery not being replaced in time, and the battery reaching its shutdown threshold, thus causing the device to not power on, during the patient event.

Event Description

A customer contacted physio control to report that their device would not power on when attempting to be used with a patient.The patient was found unconscious and not breathing by the rescue service.An ambulance arrived 18 minutes after the arrival of the rescue service and found a patient with asystole.The patient associated with the event did not survive.

Manufacturer Narrative

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.

• Brand Name: LIFEPAK(R) 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: 10741392
• MDR Text Key: 213234819
• Report Number: 0003015876-2020-01594
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: P170018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CR2
• Device Catalogue Number: 99512-000233
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 3015876-01/14/2021-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 40 YR