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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVE INTERNAL HANDLES; INTERNAL HANDLE (STEM)
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ZOLL MEDICAL CORPORATION AUTOCLAVE INTERNAL HANDLES; INTERNAL HANDLE (STEM) Back to Search Results
Model Number 1011-0141-03-16
Device Problem Failure to Discharge (1169)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing, the associated device failed to discharge using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The internal handles were returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty cable on the internal handle.Analysis for reports of this type has not identified an increase in trend.
 
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Brand Name
AUTOCLAVE INTERNAL HANDLES
Type of Device
INTERNAL HANDLE (STEM)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key5837534
MDR Text Key51177545
Report Number1220908-2016-01878
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number1011-0141-03-16
Device Catalogue Number1011-0141-03-16
Device Lot NumberN/A
Other Device ID Number00847946022884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received07/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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