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

Model Number 860315

Device Problem Connection Problem (2900)

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

Event Type  Injury  

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 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
• Type of Device: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8725451
• MDR Text Key: 148905838
• Report Number: 1218950-2019-04476
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: (01)00884838026582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other