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

Model Number R SERIES

Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device's pacer rate was not adjustable, was unable to increase pacer output and failed self-test.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

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

• Brand Name: R 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: 5450436
• MDR Text Key: 38699251
• Report Number: 1220908-2016-00413
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: R SERIES
• Device Catalogue Number: R SERIES
• Other Device ID Number: 00847946002336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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