MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION E SERIES DEFIBRILLATOR; DEFIBRILLATOR/PACEMAKER

Model Number E SERIES

Device Problems Device Displays Incorrect Message (2591); Improper Alarm (2951)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed "defib fault 72", "defib disabled" and "pacer disabled" messages.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.The customer was contacted for return of the suspect product.The customer has responded and indicated the product will not be returning to zoll.

• Brand Name: E SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 6693151
• MDR Text Key: 79273474
• Report Number: 1220908-2017-01553
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946010409
• UDI-Public: 00847946010409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: E SERIES
• Device Catalogue Number: E SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2010
• 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