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

Model Number R SERIES

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem Tachycardia (2095)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device issued a "shock advised" prompt for a heart rhythm they believe was non-shockable.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned to zoll medical corporation for evaluation.The customer's report of patient movement during transport causes ecg artifact, which may lead to inappropriate shock recommendations.The r series operator's guide warns, "do not use the unit in aed mode or advisory mode during patient movement.A patient must be motionless during ecg rhythm analysis.Do not touch the patient during analysis.If transporting the patient in the hospital, cease all movement before beginning ecg analysis." this report has been attributed to improper use of the device by the end user.Analysis of reports of this type has not identified an increase in trend.

• Brand Name: R SERIES DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR/PACEMAKER
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• Manufacturer Contact: scott august ; 269 mill road; chelmsford, MA 01824 ; 9784219552
• MDR Report Key: 18399820
• MDR Text Key: 331411422
• Report Number: 1220908-2023-04945
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00847946017200
• UDI-Public: 00847946017200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

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: R SERIES
• Device Catalogue Number: R 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: 12/07/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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