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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 ELECTROCARDIOGRAPH

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PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 ELECTROCARDIOGRAPH Back to Search Results
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.

 
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Brand NamePAGEWRITER TC50
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
MDR Report Key6521719
MDR Text Key73683448
Report Number6521719
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
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 Received04/26/2017
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberTC50
Device Catalogue Number29600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/24/2017
Device Age1 yr
Event Location Outpatient Treatment Facility
Date Report TO Manufacturer04/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/26/2017 Patient Sequence Number: 1
Treatment
ECGS ON DIFFERENT SITES SHOWED SYMPTOMS OF GIVING; NOT APPLICABLE.
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