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

Model Number R SERIES

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported malfunction was observed during review of the activity logs.However, the reported problem could not be duplicated.Review of the activity logs showed occurences of "check pads" and "poor pad contact" messages.It is important to mention that other factors can contribute to this type of report that may not be associated to the device.A "check pads" message can be normal device operation when performing the pacer test when the multi-function cable is not connected or if there is a poor connection.The multi-function cable was not returned for evaluation.The device passed final testing was recertified and returned to the customer.No trend is associated with reports of this type.

Event Description

Complainant alleged that during biomed testing the device did not output pacer current.Complainant indicated that there was no patient involvement in the reported malfunction.

• 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: 5376740
• MDR Text Key: 36344550
• Report Number: 1220908-2016-00056
• 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
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• 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: 01/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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