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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY, PADDLES, ENG; MSERIES PADDLES
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ZOLL MEDICAL CORPORATION ASSY, PADDLES, ENG; MSERIES PADDLES Back to Search Results
Model Number 1001-001150-01
Device Problem Failure to Deliver Shock/Stimulation (1133)
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 during functional testing, the associated device failed to discharge using these paddles.Complainant did not indicate that there was any patient involvement in 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, PADDLES, ENG
Type of Device
MSERIES PADDLES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key16023443
MDR Text Key305914942
Report Number1220908-2022-05015
Device Sequence Number1
Product Code LDD
UDI-Device Identifier00847946023010
UDI-Public00847946023010
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 11/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1001-001150-01
Device Catalogue Number1001-001150-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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