MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50; ELECTROCARDIOGRAPH

Model Number TC50

Device Problems Device Inoperable (1663); Communication or Transmission Problem (2896)

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

Event Date 04/24/2017

Event Type  malfunction  

Event Description

Last week, we received two devices on different days for ecg failing.When diagnosing, it appeared the communication card on both devices failed.We contacted the (b)(4) to order the failing parts, (b)(4) declined to sell us the parts, and only offered a service contract for the ecg or a flat rate of (b)(4) for any bench repair at their facility.We declined the offers and requested to have the ability to purchase parts and do the repair.This morning, we received the same report for exactly the same problem on two other devices.Two major cardiac clinics are out of ecg services due to this issue and due to the non-cooperative behavior of (b)(4) to supply parts to their devices.Manufacturer response for ecg, (b)(4) (per site reporter).No answer as to providing parts to support their devices.Their first impression is that it could be a software revision issue, and they recommended updating the software from a.06.07 to a.06.08.

• Brand Name: PAGEWRITER TC50
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6521719
• MDR Text Key: 73683448
• Report Number: 6521719
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TC50
• Device Catalogue Number: 29600
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2017
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ECGS ON DIFFERENT SITES SHOWED SYMPTOMS OF GIVING; NOT APPLICABLE.