MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK; INTERNAL PADDLE

Model Number 1011-0139-02

Device Problem Failure to Discharge (1169)

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 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.

Manufacturer Narrative

The device was returned to zoll medical corporation; the reported malfunction was duplicated and attributed to a faulty switch on the internal paddles.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: ASSY,M AIH, 1.6 DIA, W/SWITCH, 100-120V ONLY, PACK
• 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: 7596435
• MDR Text Key: 110903489
• Report Number: 1220908-2018-01616
• Device Sequence Number: 1
• Product Code: LDD
• UDI-Device Identifier: 00847946022334
• UDI-Public: 00847946022334
• 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: 05/24/2018

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
• Device Operator: Other
• Device Model Number: 1011-0139-02
• Device Catalogue Number: 1011-0139-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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