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

Model Number 1011-0139-03

Device Problem Failure to Discharge (1169)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during an open heart procedure to treat a patient (age & gender unknown) the internal handle failed to discharge.The clinician used another set of internal handles and was able to shock the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

The reported malfunction was observed and attributed to an open between pin 2 and pin 4 within the internal handles.The customer received a replacement set of internal handles.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: ASSY,MAIH, 2.7 DIA, W/SWITCH, 100-120V ONLY
• 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: 6118283
• MDR Text Key: 60871002
• Report Number: 1220908-2016-02891
• Device Sequence Number: 1
• Product Code: LDD
• 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: 11/03/2016

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: 1011-0139-03
• Device Catalogue Number: 8011-0139-03
• Other Device ID Number: 00847946022341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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