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

Model Number M SERIES

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Complainant alleged that during biomed testing the device was unable to adjust pacer rate.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

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

• Brand Name: M SERIES
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 4230530
• MDR Text Key: 4970163
• Report Number: 1220908-2014-02548
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M SERIES
• Device Catalogue Number: M SERIES
• Other Device ID Number: 00847946006501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2009
• 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