MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY; INTERNAL PADDLE

Model Number	1011-0139-04
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
Event or Problem Description
Complainant alleged that during a routine shift check by a clinician, the associated device failed to discharge using these internal handles.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
The internal handles were received for evaluation with the paddle wires cut through on the shock button side.The shock button was observed stuck in place and unable to move.Due to the damage, the internal handles were unable to be tested for discharge functionality.After dissection/disassembly of the handles we were able to confirm that the internal components had migrated to a void inside the handle cavity causing the shock button not to function.It was determined that extreme heat of 400 degrees or more would be required to cause the observed internal components migration well outside recommended temperature exposure for the handles.The cause of the exposure could not be firmly established with the end user.However, this circumstance appears to be isolated to this facility.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY
• Common Device Name: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8355001
• Report Number: 1220908-2019-00374
• Device Sequence Number: 2127323
• Product Code: LDD
• UDI-Device Identifier: 00847946022358
• UDI-Public: 00847946022358
• 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): 01/30/2019

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: 1011-0139-04
• Device Catalogue Number: 8011-0139-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1