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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR

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ZOLL MEDICAL CORPORATION AED PLUS; DEFIBRILLATOR Back to Search Results
Model Number AED PLUS
Device Problems Unable to Obtain Readings (1516); Failure to Analyze Signal (1539)
Patient Problem Necrosis (1971)
Event Date 12/09/2023
Event Type  Death  
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 treat a 68-year-old male patient, the device was unable to detect the attached pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
 
Manufacturer Narrative
This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (medical device problem code).Evaluation: the customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.
 
Event Description
Complainant alleged that while attempting to treat a 68-year-old male patient, the device was unable to analyze.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
 
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Brand Name
AED PLUS
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key18425503
MDR Text Key331766867
Report Number1220908-2023-05023
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946002152
UDI-Public00847946002152
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011541/P160
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberAED PLUS
Device Catalogue NumberAED PLUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/02/2024
Supplement Dates Manufacturer Received12/11/2023
Supplement Dates FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
Patient SexMale
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