MAUDE Adverse Event Report: PHYSIO CONTROL (STRYKER), INC. LIFEPAK 15; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number LIFEPAK 15

Device Problems Nonstandard Device (1420); Defective Device (2588); Charging Problem (2892)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

Manufacturing defect with defibrillator charger/power supply.Affecting 16 defibrillators so far.They will not charge and also prevents the defibrillator from being turned on when plugged in.There has not been patient impacts to date but does warrant possible recall.Reference reports: mw5118787, mw5118788, mw5118789, mw5118790, mw5118791, mw5118793, mw5118794, mw5118795, mw5118796, mw5118797, mw5118798, mw5118799, mw5118800, mw5118801, mw5118802.Refer to additional documents in i2k.

• Brand Name: LIFEPAK 15
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO CONTROL (STRYKER), INC.
• MDR Report Key: 17200104
• MDR Text Key: 317968127
• Report Number: MW5118792
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIFEPAK 15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1