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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY, PACKA; INTERNAL PADDLE

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ZOLL MEDICAL CORPORATION ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY, PACKA; INTERNAL PADDLE Back to Search Results
Model Number 1011-0139-03
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 associated defibrillator failed to discharge using these internal handles.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
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Brand Name
ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY, PACKA
Type of Device
INTERNAL PADDLE
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 Key17772383
MDR Text Key323695571
Report Number1220908-2023-03554
Device Sequence Number1
Product Code LDD
UDI-Device Identifier00847946022341
UDI-Public00847946022341
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/29/2023
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 Operator Other
Device Model Number1011-0139-03
Device Catalogue Number8011-0139-03
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/19/2023
Supplement Dates Manufacturer Received08/29/2023
Supplement Dates FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2022
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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