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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 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 functional testing these internal handles failed to discharge.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The malfunction was attributed to the internal handles.The customer received a replacement set of internal handles to resolve the malfunction.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 Key5998395
MDR Text Key57053515
Report Number1220908-2016-02530
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 10/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2016
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
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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