MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number 30000003101010013

Device Problems Defective Alarm (1014); Battery Problem (2885)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Zoll r series defibrillator used during a code event, the patient was not able to be resuscitated and family was allowed to say good bye to them.During that time, the unit's batteries were low and finally depleted.Staff was not able to hear alarm on the device when it alerted to the extreme low battery condition, when inquiring with zoll, the unit worked as intended but staff felt the alarm was low given other cues the unit gives.Not adjust could be made to volume or change the alert to a longer time that the battery was about to expire.

• Brand Name: R SERIES
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION
• MDR Report Key: 15619264
• MDR Text Key: 301909701
• Report Number: 15619264
• 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: 09/26/2022

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
• Device Model Number: 30000003101010013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1