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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
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ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES) Back to Search Results
Model Number 1011-0139-03
Medical Device Problem Code Energy Output Problem (1431)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated defibrillator's defib output was out of specification using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Additional Manufacturer Narrative
The complainant was contacted for return of the device.The customer has responded and indicated the device will not be returning to zoll.
 
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Brand Name
AUTOCLAVABLE INTERNAL HANDLES (MSERIES)
Common Device Name
INTERNAL HANDLES
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key6918775
Report Number1220908-2017-02419
Device Sequence Number16439602
Product Code LDD
UDI-Device Identifier00847946022341
UDI-Public00847946022341
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Model Number1011-0139-03
Device Catalogue Number8011-0139-03
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/15/2017
Supplement Date Received by Manufacturer09/15/2017
Initial Report FDA Received Date10/05/2017
Supplement Report FDA Received Date10/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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