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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES; DEFIBRILLATOR
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES; DEFIBRILLATOR Back to Search Results
Model Number 1011-0140-04
Device Problem Failure to Discharge (1169)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The internal handles were returned to zoll medical corporation for evaluation; the malfunction was duplicated and attributed to a open pin on the internal handle.The internal handles were scrapped.Analysis for reports of this type has not identified an increase in trend.
 
Event Description
Complainant alleged that during biomed testing, the associated device 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
DEFIBRILLATOR
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key7534642
MDR Text Key108946333
Report Number1220908-2018-01378
Device Sequence Number1
Product Code LDD
UDI-Device Identifier00847946022402
UDI-Public00847946022402
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1011-0140-04
Device Catalogue Number8011-0140-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2008
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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