MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION AUTOCLAVABLE HANDLE ASSEMBLY WITHOUT SWITCH; INTERNAL PADDLE

Model Number 8011-0500

Device Problem Energy Output Problem (1431)

Patient Problem No Information (3190)

Event Date 02/02/2018

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's output was below specification 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 external paddle set was returned to zoll medical corporation.The customer physically cut the cable from the handle set by their procedure rendering the investigation limited.Device information and logs were not available as part of the investigation.Based on what were able to evaluate, we did not observe the customer report.The external paddle set was scrapped.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: AUTOCLAVABLE HANDLE ASSEMBLY WITHOUT SWITCH
• 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: 7293436
• MDR Text Key: 100832418
• Report Number: 1220908-2018-00490
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8011-0500
• Device Catalogue Number: 8011-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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