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

Model Number X SERIES

Device Problems Loss of Power (1475); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

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 a routine shift check by a clinician, the device inappropriately shut down and failed self test for ecg.Complainant indicated that subsequent testing did not duplicate the reported malfunction.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.Instead, the device activity log was returned for review.The reported malfunction was observed during review of the activity logs.However, root cause could not be firmly established using the logs.Analysis of reports of this type has not identified an increase in trend.

Manufacturer Narrative

The device was returned to zoll medical corporation; the malfunction was observed during review of the device's history log.The device was put through extensive testing without duplicating the malfunction.The device's monitor board was replaced as a precaution.The device passed the final test procedure, was recertified, and returned to the customer.Analysis for reports of this type has not identified an increase in trend.

• Brand Name: X SERIES
• 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: 6094549
• MDR Text Key: 60024334
• Report Number: 1220908-2016-02782
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

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: X SERIES
• Device Catalogue Number: X SERIES
• Other Device ID Number: 00847946012717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/15/2016; 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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