MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. LIFE PAK CR PLUS DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The lifepak cr plus defibrillator electrodes and batteries have been unavailable.These devices are necessary for patients and visitors who experience cardiac arrest and require basic life support with an aed.

• Brand Name: LIFE PAK CR PLUS DEFIBRILLATOR
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC.; 11811 willows rd ne; redmond WA 98052
• MDR Report Key: 15592691
• MDR Text Key: 301735179
• Report Number: 15592691
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1