MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD PASSPORT 12 PATIENT MONITOR

Model Number 6105F-PA00001

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

It was determined that the iv pole that is attached to the patient's bed hit the underside of the monitor from the back while the bed was being pulled out of its normal parked location.According to the customer, it was this upward force that dislodged the monitor from the mount.

Event Description

It was reported that the customer bumped the quick release mechanism on the passport 12 monitor mount.The passport 12 monitor fell from the mount, and hit a patient in the head.The patient suffered a laceration.A ct was subsequently performed-no damage noted on ct.The customer confirms the patient's ct was normal.

• Brand Name: PASSPORT 12 PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guandong 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: serena chen ; 1203 nanhuan avenue; guangming district; shenzhen, shenzhen 51810-6 ; CH 518106
• MDR Report Key: 10756961
• MDR Text Key: 214157235
• Report Number: 3009156722-2020-00010
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2020

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: 6105F-PA00001
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 10/29/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other