PAGEWRITER TC70 453564561421

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for PAGEWRITER TC70 453564561421 manufactured by Philips Medical Systems.

Event Text Entries

[180750683] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9750324
MDR Report Key9750324
Date Received2020-02-25
Date of Report2020-01-08
Date of Event2019-12-15
Report Date2020-01-08
Date Reported to FDA2020-01-08
Date Reported to Mfgr2020-02-25
Date Added to Maude2020-02-25
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePAGEWRITER
Generic NameELECTROCARDIOGRAPH MACHINE
Product CodeDPS
Date Received2020-02-25
Model NumberTC70
Catalog Number453564561421
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN RD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-25

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