MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TOUCH CARDIOGRAPH; PAGEWRITER TC70 CARDIOGRAPH

Model Number	860315
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The field service engineer(fse) ran a pass/fail diagnostic on the complaint pim.The pim passed, therefore, no failure was found.The customer was sent a replacement pim and leadset.A field service engineer(fse) went onsite and replaced the pim and leadset and ran a pass/fail diagnostic to ensure the new set was functioning correctly.Investigation revealed that the failure could not be recreated, therefore, cause is unknown.
Event or Problem Description
Customer reported that there was a connection issue between the unit and the pim.This caused a delay in treatment during an emergency situation.The connection issue caused a delay in treatment.Customer had to use a second ekg unit on the patient.

• Brand Name: PAGEWRITER TOUCH CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8725451
• Report Number: 1218950-2019-04476
• Device Sequence Number: 2522219
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: (01)00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other