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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION AED PRO; DEFIBRILLATOR Back to Search Results
Model Number AED PRO
Device Problem Mechanics Altered (2984)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during functional testing, the device powered up in the incorrect mode.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The device was returned to zoll medical corporation.The reported problem was verified during evaluation.A system interconnection cable was replaced to resolve the issue.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
AED PRO
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key15225654
MDR Text Key297965909
Report Number1220908-2022-03029
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAED PRO
Device Catalogue NumberAED PRO
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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