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

Model Number 0998-UC-0700-01

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The facility reported the patient asked nursing staff several times to go outside and smoke.The patient was on oxygen and now allowed to smoke.The patient apparently went into the bathroom and smoked.The facility reports after the incident a charred cigarette lighter was found in the bathroom.The facility communicated to mindray that the damage to the telepack appears to be external and there is nothing to suggest that the telepack was the cause of the fire.(b)(4).

Event Description

It was reported that a patient being monitored on a telepack 608 in use with the panorama central station emerged from the bathroom "on fire".The facility reported the patient suffered burns.

• Brand Name: PANORAMA CENTRAL STATION WITH TELEMETRY
• Type of Device: CENTRAL MONITORING SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13 baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzen 51810 8; CH 518108
• MDR Report Key: 7891933
• MDR Text Key: 120825955
• Report Number: 3009156722-2018-00009
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/19/2018,08/27/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 0998-UC-0700-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2018
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other