MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER; ELECTROCARDIOGRAPH MACHINE

Model Number TC70

Device Problem Signal Artifact/Noise (1036)

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

Event Date 12/15/2019

Event Type  malfunction  

Event Description

There were four events related to artifacts on the ekg machine despite proper lead placement and troubleshooting.The stimulator test was performed [date redacted] and the pim was swapped [date redacted].(b)(6) (patient #1).Occurred: [date redacted] at 0400.Reported: [date redacted] at 0613."the unit ekg machine is improperly working, during rrt today in 5c room 111 at approximately 0400-0500, the ekg machine showed nothing but giant artifacts despite minimal pt movement, multiple proper skin cleanings and multiple electrode replacements the ekg machine continued to be impossible to read with giant green scribbles on the display.The doctors are unable to properly assess the patient due to the faulty equipment asking repeatedly and repeatedly of the nurses for a reading however rn's are unable to obtain when needed because of the machine.This is an every day occurrence with this machine, even during non rrts (rapid response team) uses the ekg machine does not display proper readings due to impossible to read giant total screen artifacts, takes great difficulty to get to work properly such as unconventional techniques such as difficult positional placements of the wires for example holding the wires in a "funny unique way".There was even an incident today of its use just before the rrt on a cooperative calm pt this shift that the ekg was displaying impossible to read giant artifacts, the entire screen is green with scribbles.There have been at least four to five rrts that i personally have been in this year that the ekg machine has given great difficulty for the whole team to assess the patient properly in the manner described above leaving the doctors to being unable to assess the patient and asking repeatedly of the nurses to "get a reading" to no fault of ours.Biomed swapped pim on [date redacted].[date redacted]: occurred.[date redacted]: reported to biomed.Friday [date redacted] we had another issue with 5c ekg machine during a rrt (rapid response team).The ekg machine did not clearly pick up the waveforms.I was at the bedside and we ensured that all leads were connected appropriately.We did not want to delay any longer, and swapped 5c with 5a's and it worked without any problem.I spoke to (biomed) and he looked at 5c's machine.Initially thinking it was user error, 5c's machine worked for an ekg that same morning.But with closer examination the problem continued.I swapped out 5c's ekg pim.I have not heard another complaint/issue with the machine since the swap.(b)(6) (patient #2).[date redacted] 2300: third event occurred.Ekg machine broken/ not reading.Bio med employee comes and "services machine." states that is it working, tells nurses they need to clean and then dry the patient skin and apply clean new electrodes, tells the unit he "cannot duplicate the issue." except the problem is that the biomed employee is testing on a hand held device and not a live person.Ekg machine does not serve its purpose.In this instance, i the rn cleaned and dried pt's skin, applied new electrodes, could not get ekg reading.I the rn then had to go to icu and borrow their ekg machine, to which it worked instantly with the very same pt, very same electrodes that the 5c machine does not read.The 5c ekg machine is showing giant artifacts.I the rn have two more scheduled ekgs tonight for this pt, to which i will be borrowing from icu.What happens when icu needs their ekg machine but it is over here in 5c while i am performing this ekg on this pt for his critical and elevating troponin levels? what happens when icu states i cannot borrow their ekg machine because they need it yet my patient here in 5c is in need of an ekg in order for the doctor to assess and direct care for the patient? (b)(6) (patient #3).Reported date [date redacted].Ekg machine does not work properly.Full of artifact despite trouble shooting by several other rns.Report about ekg machine has been made many times before and the biomed worker told us "problem could not be duplicated", yet the problem persists.When i float to other floors i don't encounter this issue.

• Brand Name: PAGEWRITER
• Type of Device: ELECTROCARDIOGRAPH MACHINE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 9750324
• MDR Text Key: 180750683
• Report Number: 9750324
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2020

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: Health Professional
• Device Model Number: TC70
• Device Catalogue Number: 453564561421
• 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: 01/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 63