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

Model Number "8900-0224-01 8900-021"

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Syncope/Fainting (4411); Heart Block (4444)

Event Date 11/14/2022

Event Type  Death  

Event Description

Pt came in via ems collapsed at gas station, complete heart block, hr 80 to 20, gray enroute, coded, defib pads appeared to be tracing on the monitor but the skin was not twitching at a jolt.Replaced pads and started twitching.Pt expired.Don't think any impact to pt but reported as it was odd that 2nd pads reacted.Monitor indicated no issue.

• Brand Name: ONESTEP-CPR COMPLETE
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA 01824
• MDR Report Key: 16294040
• MDR Text Key: 308829032
• Report Number: MW5114645
• 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: 01/31/2023

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
• Device Expiration Date: 03/13/2023
• Device Model Number: "8900-0224-01 8900-021"
• Device Lot Number: 1121C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White