MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY; INTERNAL PADDLE

Model Number	1011-0139-03
Medical Device Problem Code	Failure to Discharge (1169)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to treat a (b)(6) male patient, the associated defibrillator was unable to discharge using these internal handles.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty pin.The handles were scrapped and the customer received a replacement.It's important to mention these handles are over a 11 years of age and are recommended to be replaced after either 100 sterrad or 50 autoclave cycles of sterilization.Zoll also recommends a functional inspection prior to each use.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY
• Common Device Name: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 7228512
• Report Number: 1220908-2018-00214
• Device Sequence Number: 13712166
• 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): 01/10/2018

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
• 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: 02/08/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR