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

Model Number MSERIES BI-PHASIC

Device Problems Pacing Problem (1439); Activation Problem (4042)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional procode = mkj.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.

Event Description

Complainant alleged that during biomed testing, the device was unable to pace and select energy level.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

The device was returned to zoll medical (b)(4); the customer received a replacement front panel membrane to resolve the malfunction.Our analysis of data indicates for reports of this type is attributed to high contact resistance within the front panel membrane and that the keys do respond however they need to be pushed harder to activate.Due to the fact that the device can still administer therapy, reports of this nature do not typically meet the criteria for reportability.

• 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: 8803139
• MDR Text Key: 151454810
• Report Number: 1220908-2019-01965
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K990762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2004
• 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