MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DIGITRAK XT HOLTER RECORDER; DIGITRAX XT HOLTER RECORDER

Model Number 860322

Device Problem Data Problem (3196)

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

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is completed.

Event Description

The customer reported having data integrity issues with philips holter monitors via lifewatch services.A patient's cardiology information was merged with another patient, such that the patient was believed to have atrial fibrillation when he did not.The customer is concerned about a data integrity issue and was unable to receive help with a resolution via lifewatch services.Note that as of the time of this report, the correct philips holter product number is not known.Additional information has been requested of the customer.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The patient was given medication that was not needed, but there was no harm to the involved patient.

• Brand Name: DIGITRAK XT HOLTER RECORDER
• Type of Device: DIGITRAX XT HOLTER RECORDER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6889496
• MDR Text Key: 87629981
• Report Number: 1218950-2017-06580
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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