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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 Deliver Shock/Stimulation (1133)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during functional testing, the device failed to discharge.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The internal handles were returned to zoll medical corporation for evaluation.The customer's report was observed and attributed to the internal handles.Testing confirmed that the shock button was not functioning.The internal handles were scrapped.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
MDR Report Key9939048
MDR Text Key187044552
Report Number1220908-2020-00921
Device Sequence Number1
Product Code LDD
Combination Product (y/n)N
PMA/PMN Number
K963781
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
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 Manufacturer05/27/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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