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

Model Number MSERIES BI-PHASIC

Device Problem Device Displays Incorrect Message (2591)

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 displayed a unknown "pacer fault" message.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The malfunction was observed during incoming testing; however after disassembling the device to determine root cause, the malfunction was no longer seen.The customer declined repair and the device was returned not certified and labeled not for clinical use.No trend is associated with reports of this type.

Event Description

Complainant alleged that during a routine shift check by a clinician, the device displayed "pacer fault 116" and "pacer disabled" messages.Complainant indicated that there was no patient involvement in the reported malfunction.

• Brand Name: M 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: 5268615
• MDR Text Key: 32933592
• Report Number: 1220908-2015-03180
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MSERIES BI-PHASIC
• Device Catalogue Number: M SERIES
• Other Device ID Number: 00847946003937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2001
• 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