Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES (MSERIES); INTERNAL PADDLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Complainant alleged that during functional testing, the associated device failed to discharge using these internal handles.Complainant did not indicate that there was any patient involvement in the reported malfunction.
 
Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
 
Manufacturer Narrative
The customer was contacted for return of the product.The customer has responded and indicated that the product was discarded and will not be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
scott august
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key17405370
MDR Text Key320033327
Report Number1220908-2023-02914
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 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
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
Date Manufacturer Received07/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-