MAUDE Adverse Event Report: STRYKER LIFEPAK 15 MONITOR / DEFIBRILLATOR

Device Problems Image Display Error/Artifact (1304); Failure to Read Input Signal (1581)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/18/2019

Event Type  Death  

Event Description

In the process of responding to the cardiac arrest, the lp15 locked-up, meaning that a grey box appeared that obstructed the monitor's display.Additionally, there was no response from the keypad and device function during this time.This lasted for approx 10-15 seconds.The device was immediately decommissioned and returned to the mfr for testing.Upon mr cramer becoming aware of the situation, on (b)(6) 2019, amr began steps to initiate gathering the data for this report.

• Brand Name: LIFEPAK 15 MONITOR / DEFIBRILLATOR
• Type of Device: MONITOR / DEFIBRILLATOR
• Manufacturer (Section D): STRYKER; redmond WA
• MDR Report Key: 8453395
• MDR Text Key: 139988352
• Report Number: 8453395
• Device Sequence Number: 0
• Product Code: DRT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2019
• Device Age: 15 MO
• Event Location: Outpatient Treatment Facility
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 85