MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS ZYMED HOLTER SOFTWARE; ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM

Model Number	860292
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported they received the recorder back with the wrong patient name.There was no patient involved.
Additional Manufacturer Narrative
Serial number is unknown.Serial number and udi were incorrectly populated in the initial thirty day report and should have blank.

• Brand Name: ZYMED HOLTER SOFTWARE
• Common Device Name: ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8903131
• Report Number: 1218950-2019-06183
• Device Sequence Number: 1828608
• Product Code: MLO
• UDI-Device Identifier: 00884838000476
• UDI-Public: (01)00884838000476
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K992197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 860292
• Device Catalogue Number: 860322
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1