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

Model Number MSERIES BI-PHASIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complainant alleged that during biomed testing, the unit was not functioning properly.Complainant indicated that there was no patient involvement in the reported malfunction.

Manufacturer Narrative

This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Evaluation results: the reported malfunction of a loose pacer knob was verified.The control board was replaced to resolve the malfunction.It was determined during the investigation that the front panel of the device was physically broken, including a switch on the control board (pacer knob switch).Due to the physical damages to the deivce, this report has been attributed to user mis-handling of the device.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.

Event Description

Complainant alleged that during biomed testing, the device's pacer control knob was loose.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: 7731135
• MDR Text Key: 115367825
• Report Number: 1220908-2018-02141
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00847946000684
• UDI-Public: 00847946000684
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2000
• 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