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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 8011-0501-01
Device Problem Device Operational Issue (2914)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that during functional testing, the internal handles did not function.No further information was available.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
The complainant was contacted for return of the device.The device has not been returned to zoll for evaluation.
 
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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 Key7565347
MDR Text Key109928416
Report Number1220908-2018-01524
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 05/14/2018
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
Device Operator Other
Device Model Number8011-0501-01
Device Catalogue Number8011050101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/14/2018
Initial Date FDA Received06/04/2018
Supplement Dates Manufacturer Received05/14/2018
Supplement Dates FDA Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
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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