MAUDE Adverse Event Report: EDAN INSTRUMENTS, INC. EDAN; HOLTER SYSTEM

Model Number HOLTER SYSTEM ANALYSIS SOFTWARE

Device Problems Computer Software Problem (1112); Nonstandard Device (1420)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation finds that when the notch filter, which is off by default, of v1.22 and v1.23 pc based analysis software is on, the filtered ecg waveform may be distorted.There will be no such problem if the notch filter is off and the recorder is not affected by this problem.

Event Description

Customer reported an event for ecg trace of a patient displayed by holter system analysis software was wrongly recognized as brugada syndrome and further confirmation by physician was required.No patient death or injury was reported.

• Brand Name: EDAN
• Type of Device: HOLTER SYSTEM
• Manufacturer (Section D): EDAN INSTRUMENTS, INC.; 15 jinhui rd,jinsha community; kengzi sub-district, pingshan; shenzhen, 51812 2; CH 518122
• Manufacturer (Section G): EDAN INSTRUMENTS, INC.; 15 jinhui rd, jinsha community; kengzi sub-district, pingshan; shenzhen, 51812 2; CH 518122
• Manufacturer Contact: alice yang ; 15 jinhui rd, jinsha community; kengzi sub-district, pingshan; shenzhen, guangdong 51812-2 ; CH 518122
• MDR Report Key: 8635774
• MDR Text Key: 146224325
• Report Number: 3003971136-2019-00001
• Device Sequence Number: 0
• Product Code: DQK
• Reporter Country Code: IT
• PMA/PMN Number: K151787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HOLTER SYSTEM ANALYSIS SOFTWARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 15 YR