MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE INTERNAL HANDLES

Model Number	1011-0139-03
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
Event or Problem Description
Complainant alleged that while attempting to treat a trauma arrest patient (age & gender unknown), the associated defibrillator failed to discharge using these internal handles.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.Please reference medwatch report 1220908-2017-01932 for a similar event reported from the same customer.
Additional Manufacturer Narrative
The internal handles were returned to zoll medical corporation for evaluation.Testing of the internal handles by discharging different joule settings while stressing the cable in different areas was not able to duplicate the customer's report.The internal handles passed visual inspection and all final system level testing.The handles were recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVABLE INTERNAL HANDLES
• Common Device Name: INTERNAL HANDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 6807154
• Report Number: 1220908-2017-01973
• Device Sequence Number: 132068
• Product Code: LDD
• UDI-Device Identifier: 00847946022341
• UDI-Public: 00847946022341
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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 Number: 1011-0139-03
• Device Catalogue Number: 8011-0139-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1