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

Model Number	860315
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Insufficient Information (4580)
Date of Event	06/02/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the tc70 interpreted an ecg incorrectly and missed prolonged qt interval as the interpretation.It was reported that the patient passed away later that day after being released from the hospital.
Event or Problem Description
The customer reported that the tc70 interpreted an ecg (electrocardiogram) incorrectly and missed prolonged qt interval as the interpretation.It was reported that the patient passed away later that day after being released from the hospital.The device was in clinical use at the time the reported issue was discovered.Philips technical support was able to remotely interview the customer with the reported problem via phone conversation and emails.According to the provided information, on (b)(6) 2022, prior to the patient¿s discharge, a 12 lead ecg was performed twice using a pagewriter tc70 cardiograph.The first ecg was taken at 17:46.The ph100b version of the dxl 12-lead ecg algorithm identified atrial fibrillation (afib) and right bundle branch block (rbbb), also stating abnormal ecg with an unconfirmed diagnosis.The qt and qtc values (measurement made on the electrocardiogram used to assess some of the electrical properties of the heart) for this ecg were 351 ms and 502 ms, respectively.Note that ¿unconfirmed diagnosis¿ indicates that the ecg report was not overread by a qualified physician.A second ecg was taken at 19:03 which again showed rbbb, as well as sinus rhythm and a borderline short pr interval.Similarly, the readout stated abnormal ecg with an unconfirmed diagnosis.The qt and qtc values for this ecg were 577 ms and 591 ms, respectively.The patient was discharged from the hospital at 20:15.Following release from the hospital the patient passed away, with the cause of death unknown.After a review of the ecg paper print, it was found that the automated interpretation did not show a prolonged qt interval which, based on the qtc value for both ecgs, should have occurred.The doctor believes the tc70 interpreted the ecg incorrectly and missed the prolonged qt interval on the interpretation statement.The doctor stated that had the tc70 provided the correct interpretation, they would not have sent the patient home.Per the device¿s ifu (instructions for use), qtc greater than 465 ms is considered as borderline prolonged qtc.An additional 20 ms qualifies the condition as prolonged qtc.Additionally, a significantly prolonged qtc interval greater than 520 ms is considered to be due to hypocalcemia (deficiency of calcium in the bloodstream).For the first ecg, a ¿prolonged qt interval¿ statement should have displayed.For the second ecg, a ¿prolonged qt interval suggests hypocalcemia¿ statement should have displayed.According to the hospital contact, the site does not have ecg management software, nor do they save ecg files on the device¿s internal memory.The only technical readouts saved by the site are in the form of an ecg paper print, which is subsequently scanned into the medical record system.Therefore, it is not possible to evaluate why the algorithm used did not correctly generate the interpretive statement of prolonged qt interval.An issue impact assessment ((b)(4)) has been initiated.A 54 complaint search (01 jan 2018 ¿ 01 july 2022) for philips cardiograph products has found only 1 complaint which detailed as patient serious injury (s3) or (s4) harm depending on the criteria established in each in-scope sra.Over the span of this 54-month timeframe, there were 1,200,731,498 opportunities for use with philips cardiograph products.The observed residual risk is within the acceptable risk levels according to the standards of the dxl 12/16 lead ecg algorithm sra document.Based on the conclusion of this assessment, no correction or removal is required.However, it is recommended to add two new hazardous situations to all in-scope products¿ sras, one covering a missed prolonged qt interval interpretation statement, and one covering a general missed interpretation statement.Any additional investigation or action taken will be documented in the respective records.
Additional Manufacturer Narrative
H3 other text : device not returned.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14846409
• Report Number: 1218950-2022-00522
• Device Sequence Number: 2351265
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: 00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K113144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Male