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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES; INTERNAL PADDLE
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES; INTERNAL PADDLE Back to Search Results
Model Number 8011-0501-01
Device Problem Failure to Discharge (1169)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported malfunction was observed and attributed to a faulty discharge button on the internal handles.The internal handles were not repairable and were scrapped.Analysis of reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during functional testing, the associated defibrillator was unable to discharge using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
 
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Brand Name
AUTOCLAVABLE INTERNAL HANDLES
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 Key7655590
MDR Text Key113034672
Report Number1220908-2018-01810
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K963781
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
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 Manufacturer06/13/2018
Was the Report Sent to FDA? No
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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