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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); INTERNAL PADDLE
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); INTERNAL PADDLE Back to Search Results
Model Number 8011-0501-01
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 received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing, the associated defibrillator failed to discharge using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The customer's report was observed and attributed to the autoclavable handle assembly.The internal handles were scrapped to resolve the report.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
Type of Device
INTERNAL PADDLE
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key12853854
MDR Text Key282210700
Report Number1220908-2021-04013
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963781
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8011-0501-01
Device Catalogue Number8011050101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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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