MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION ZOLL R-SERIES; DEFIBRILLATOR MONITOR

Model Number R-SERIES

Device Problems Device Displays Incorrect Message (2591); Failure of Device to Self-Test (2937)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

While performing the daily defibrillator check the rn noted that the defibrillator did not indicate the 30 joule test shock to the multi-function electrode pad.Standard procedure is to connect defibrillator therapy cable to the un-opened multi-function electrode package to act as a test load for the test shock.When the user initiated the self test the defibrillator passed all checks except when trying to manually deliver test shock.The defibrillator displayed a "please replace pads" message.This same error would occur even with a different multi-function electrode attached.When the clinician inserted the therapy cable into the side defibrillator test port, the defibrillator would pass all self tests including the test shock.Unit removed some service and sent to biomedical for repair.Biomedical confirmed defibrillator's failure to complete user self test with attached multi-function electrode.Manufacturer response for defibrillator monitor, zoll r-series (per site reporter): requested rma to return to manufacturer for analysis and repair.This is a re-occurring event with the defibrillator not completing self test with multi-function electrode with this model defibrillator.Manufacturer response for multi-function electrode, onestep cpr a/a (per site reporter): this is a re-occurring event.

• Brand Name: ZOLL R-SERIES
• Type of Device: DEFIBRILLATOR MONITOR
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 mill road; chelmsford MA 01824
• MDR Report Key: 8343029
• MDR Text Key: 136276146
• Report Number: 8343029
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: R-SERIES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Type of Device Usage: N
• Patient Sequence Number: 1