MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD A5 ANESTHESIA SYSTEM

Model Number A5

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation is pending information from the customer to identify the unit involved in the event.(b)(4).

Event Description

The customer reported that approximately 2 years ago the paw gauge on the a5 anesthesia system became dislodged.This occurred prior to being used on a patient.The paw gauge was pushed back into its housing and the device continued to operate normally.There have been no reported reoccurrences of the event.No adverse event was reported.The customer's biomed investigated the event and per his conversation with the caregiver involved in the event it was acknowledged that ecg cables became wrapped around the paw gauge.The cables may have pushed the paw gauge, causing it to become dislodged.Upon the occurrence of the reported event, the customer elected as a precaution to verify that the paw gauge is fully inserted in place each time the a5 anesthesia system are cleaned.The customer did not report the event to the manufacturer at the time of occurrence as in his perspective the event was caused by user error.Recently, the biomed found a case of a dislodged paw gauge in the maude database.At this time the biomed decided to report the event to the manufacturer for consideration in future product enhancements.

• Brand Name: A5 ANESTHESIA SYSTEM
• Type of Device: ANESTHESIA SYSTEM
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; buildings 9-13, baiwangxin; high-tech industrial park; baimang, xili town, nanshan, 51810 8; CH 518108
• Manufacturer Contact: serena chen ; buildings 9-13, baiwangxin; high-tech industrial park; baimang, xili town, nanshan, shenzhen 51810-8 ; CH 518108
• MDR Report Key: 6667387
• MDR Text Key: 78471341
• Report Number: 3007222337-2017-00018
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/22/2017,06/01/2017

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: No Information
• Device Model Number: A5
• Device Catalogue Number: 0631F-01000-06
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/01/2017
• Date Report to Manufacturer: 06/22/2017
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/26/2017
• 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): Life Threatening