MAUDE Adverse Event Report: COVIDIEN LLC CABLE, ELECTRODE

Device Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2021

Event Type  malfunction  

Event Description

After disconnecting and discharging a patient who was connected to a philips mx40 physiological monitor (sn (b)(4), service# (b)(4)), the monitor continued to display a patient waveform.User removed and replaced batteries to 'reset' the device, but it continued to display a waveform for a nonexistent patient.When device was inspected by biomedical equipment specialist, it still displayed this waveform; specialist confirmed that device was not in demo or service mode.When the specialist removed the covidien adaptor (ref33541, lot 299252) to disconnect leads from mx40 device, the waveform disappeared.After resetting the adaptor, the waveform did not return and could not be duplicated in further testing.Contacted philips tech support (case# (b)(4)) to report issue; they recommended that we discontinue use of third-party equipment with mx40s, including the covidien adaptor and lead set.Attempted to contact covidien tech support by phone, but could not reach a representative within 75 minutes of holding.Fda safety report id # (b)(4).

• Brand Name: CABLE, ELECTRODE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): COVIDIEN LLC
• MDR Report Key: 12370203
• MDR Text Key: 268911836
• Report Number: MW5103501
• Device Sequence Number: 2
• Product Code: IKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1