MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE ECG SOFTWARE; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 860426

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

Customer reported an ekg was under the wrong patient.The device was not in use on a patient.

• Brand Name: INTELLISPACE ECG SOFTWARE
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10153715
• MDR Text Key: 195532493
• Report Number: 1218950-2020-03469
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00884838032408
• UDI-Public: (01)00884838032408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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