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

Model Number MSERIES

Device Problem Failure to Discharge (1169)

Patient Problem No Patient Involvement (2645)

Event Type  Malfunction  

Event Description

Complainant alleged that during a routine shift check by a clinician, the device failed to discharge. Complainant indicated that there was no pt involvement in the reported malfunction.

Manufacturer Narrative

Zoll medical corp 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 CORP; chelmsford MA
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 4507157
• MDR Text Key: 5412135
• Report Number: 1220908-2015-00184
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K972241
• 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: 01/14/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/02/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: MSERIES
• Device Catalogue Number: M SERIES
• OTHER Device ID Number: 00847946006990
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 01/19/2015
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 03/01/2000
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse