MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. PANORAMA CENTRAL STATION WITH TELEMETRY; CENTRAL MONITORING STATION

Model Number 0998-00-0190-02

Device Problem Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

This is a resubmission of the original mdr (submitted via paper copy on (b)(6) 2015) made at the request of the fda who notified the company they cannot locate the original mdr.

Event Description

Customer reported an issue with the panorama central station with telememtry, which may have affected telemetry monitoring.No patient injury was reported.

• Brand Name: PANORAMA CENTRAL STATION WITH TELEMETRY
• Type of Device: CENTRAL MONITORING STATION
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.; 1203 nanhuan avenue; guangming district; shenzhen, guangdong 51810 6; CH 518106
• Manufacturer (Section G): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.; 1203 nanhuan avenue; guangming district; shenzhen, shenzhen 51810 6; CH 518106
• Manufacturer Contact: patrice martinez ; 800 macarthur blvd; mahwah, NJ 07430 ; 2019958026
• MDR Report Key: 11510054
• MDR Text Key: 267516929
• Report Number: 3009156722-2015-00258
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 0998-00-0190-02
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1