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

Model Number 1011-0139-04

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.

Event Description

Complainant alleged that while attempting to treat a patient (age & gender unknown), the associated defibrillator failed to discharge using these attached internal handles.Complainant indicated that the clinician obtained another set of handles to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also updating information submitted on the initial medwatch report.Evaluation results: 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.

Event Description

Complainant alleged that while attempting to treat a (b)(6) year old patient (gender unknown), the associated defibrillator failed to discharge using these attached internal handles.Complainant indicated that the clinician obtained another set of handles to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

• Brand Name: ASSY,MAIH, 3.0 DIA, W/SWITCH, 100-120VONLY, PACKAG
• Type of Device: INTERNAL PADDLE
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 8293743
• MDR Text Key: 134627342
• Report Number: 1220908-2019-00186
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022358
• UDI-Public: 00847946022358
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 01/29/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 94