MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL ONE STEP CPR COMPLETE; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Device Problem Unintended Movement (3026)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

During resuscitation of patient, the zoll one step cpr complete pads migrated from the point of application which then had them improperly located.Pads had to be switched out.

• Brand Name: ZOLL ONE STEP CPR COMPLETE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 16337798
• MDR Text Key: 309303020
• Report Number: MW5114817
• 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: 02/06/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 59 KG