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U.S. Department of Health and Human Services

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

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ZOLL MEDICAL CORPORATION R SERIES; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
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.
 
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Brand Name
R SERIES
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
MDR Report Key15619264
MDR Text Key301909701
Report Number15619264
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
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 Number30000003101010013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/26/2022
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer10/17/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/17/2022
Type of Device Usage Unknown
Patient Sequence Number1
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