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

Model Number CR2

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Intermittent Loss of Power (4016)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Physio-control performed an initial evaluation of the customer's device and was unable to reproduce the reported issue.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

The distributor contacted stryker to report that their customer's device had randomly provided a shock when it was not intended.

Manufacturer Narrative

Physio-control was provided with new information regarding the patient and the reported event.The following information has been updated: adverse event/product problem was updated to: adverse event and product problem.Outcomes attributed to ae was updated to: death.Death date was updated to (b)(6) 2019.Event date was updated to: (b)(6) 2019.Type of reportable event was updated to: death.Patient code was updated to: death.There is insufficient information at this time for a clinical review by physio-control to determine the impact of the device use, as there's no electronic patient record available to determine whether the patient's ecg rhythm was shockable.The customer reported that they powered the device on and the "analyze" prompt was heard.About two seconds later the device unexpectedly shutdown.Subsequently, about three seconds later the patient's chest moved down, as expected for a shock.Therefore the healthcare providers believed a shock had been delivered.This same pattern was observed a second time, after which the electrodes were removed and manual cpr was continued.In the electronic records it can be observed that the user attempted to turn on the device and use it on the patient four times, each time, the device powered itself down due to a low battery.There was no indication in the records that a shock had been delivered.The cause of the patient's chest moving down, leading the healthcare providers to believe a shock had been delivered, could not be determined.Physio-control reviewed the electronic records and determined that the user removed the battery from the device on (b)(6) 2019, placing it back in the device at the time of the event, on (b)(6) 2019.Removing the battery from the device, does not allow the device to send notifications of low battery, or, to beep, notifying the user of the need for a replacement battery.The user failed to store the device in a ready state.By removing the battery, the device was unable to beep every 15 minutes, alerting the user to the need of a replacement battery.The cause of the device unexpectedly powering off was determined to be due to a low battery.

Event Description

The distributor contacted stryker to report that their customer's device had randomly provided a shock when it was not intended.

• 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: 8705764
• MDR Text Key: 148286102
• Report Number: 0003015876-2019-01042
• 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
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CR2
• Device Catalogue Number: 99512-000152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/17/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death