MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAGEWRITER TC70 CARDIOGRAPH; ELECTROCARDIOGRAPH

Model Number PAGEWRITER TC70 CARDIOGRAPH

Device Problems Unexpected Therapeutic Results (1631); Patient Data Problem (3197); Program or Algorithm Execution Problem (4033)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Philips pagewriter tc70 cardiograph ecgs have an identified potential use not as expected by the manufacturer that allows more than one electrocardiogram(ecg) to be attached to an order.When this occurs due to the designs of most electronic health records and particularly with cerner only one ecg is able to be viewed by most providers.This leads to the potential for an ecg that needs to be addressed to not even be visible to the providers.This use also allows for the wrong ecgs to be attached to the wrong patient and for providers to not even know there is more than one ecg attached to the order.I've worked extensively with philips and cerner and they continue to say everything is working as designed even though admitting for the huge patient safety issue.We've requested philips to rewrite their software code for the ecg machine to once using an study instance uid tag in the dicom file for the ecg to wipe that from the session so that further ecgs captured do not repeat the study instance uid.We've uncovered that many ecg manufactures are not accounting for normal health professional use of ecg machines and now that they are transitioning to direct dicom sending their reuse of a study instance uid while acceptable for other cardiac studies should never be applied to ecgs as then each ecg no longer stands apart as its own ecg and the potential for serious patient harm is there and no one is even aware of it.In my current position at a 1,032 bed hospital system i daily audit to uncover the ecgs with more than one ecg attached to an order and since (b)(6) 2022 we've had close to 800 cases i've had to fix so that the providers can see the ecgs they need to provide care for the patients.I believe there may be a huge oversight in dicom standards when they are being applied the same way to ecgs that manufacturers and engineers have overlooked in understanding clinically that every ecg needs to be separate from any other ecg captured so that each one can be actioned on as needed.We've attempted to raise this over and over with cerner and philips and they've admitted this is going on at other hospital facilities across the nation that are not even aware yet they refuse to implement changes to protect patients and i fear that a patient may be harmed by their unwillingness to address this in a timely manner or commit to making changes that would work for all vendors and products and protect all patients.Fda safety report id # (b)(4).

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 15485067
• MDR Text Key: 300654647
• Report Number: MW5112248
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: PAGEWRITER TC70 CARDIOGRAPH
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening