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U.S. Department of Health and Human Services

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

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SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD A5 ANESTHESIA SYSTEM Back to Search Results
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.
 
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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 Key6667387
MDR Text Key78471341
Report Number3007222337-2017-00018
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123211
Number of Events Reported1
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 NumberA5
Device Catalogue Number0631F-01000-06
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date06/01/2017
Date Report to Manufacturer06/22/2017
Initial Date Manufacturer Received 06/01/2017
Initial Date FDA Received06/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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