MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION R SERIES PLUS; MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

Reported from clinician: emergency/code called on patient.Zoll transport monitor brought to room for external pacing.Display indicated "leads off" when leads were confirmed and placed on patient.On investigation by staff involved during event, lead cable not attached to ecg port on zoll.Investigation findings: problem the wrong ecg connect was plugged into back of the defib, the one plugged in is for use with a different type pad that is not used at our institution.The connector was covered by a transport pouch and was not easily identifiable that the wrong cable was plugged in.Biomedical engineering identified that the multifunction cable has and additional "ecg connector" that is part of the cable and cannot be removed unless the entire cable is replaced.Our institution discussed the findings at code committee and several potential solutions were discussed.Plan of action for short term resolution was to: cover the auxiliary ecg cable connector pins from the multi-function cable using a plastic cap.Add label to the connector indicating "do not use this end" longer term plan: replace all carry cases in transport defibrillators with side pouched so that cable connections are visible to users replace all current multi function cables with "multi-function cable without the auxiliary ecg connector ((b)(6) each).Manufacturer response for defibrillator, r series plus (per site reporter).Unknown other than discussions about purchasing new cable without auxiliary connector cable.

• Brand Name: R SERIES PLUS
• Type of Device: MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
• Manufacturer (Section D): ZOLL MEDICAL CORPORATION; 269 & 271 mill road; chelmsford MA 01824
• MDR Report Key: 7402319
• MDR Text Key: 104547894
• Report Number: 7402319
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2018,03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.