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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 not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the aed device powered on in manual mode. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction. Please reference medwatch report 1220908-2022-02259 for a similar event reported from the same customer.
 
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Brand NameAED PRO
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key14835552
MDR Text Key295646680
Report Number1220908-2022-02262
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946016142
UDI-Public00847946016142
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
Type of Report Initial,Followup,Followup
Report Date 06/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAED PRO
Device Catalogue NumberAED PRO
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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