MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD A7 ANESTHESIA SYSTEM

Model Number A7 ANESTHESIA SYSTEM

Device Problems Air Leak (1008); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

The company representative evaluated the a7 anesthesia delivery system and observed that the paw gauge was displaying 30 cm h20 even though no pressure was applied.The gauge was replaced and the system was confirmed to perform to established specifications.The gauge was evaluated and it was observed that the needle indicator was detached and was no longer mechanically bonded to the gauge mechanism, however, this is not a condition attributable to the dislodge of the gauge; the cause of the paw gauge becoming dislodged is undetermined at this time.

Event Description

The customer reported a leak coming from the paw gauge on the a7 anesthesia delivery system and that the patient was not properly ventilated or oxygenated for a period of 5 minutes.The patient coded and was defibrillated, no permanent sequels resulted and the patient did well post-operatively.The customer indicated that the paw gauge had become dislodged at some point during use and caused the leak.The customer could not recall if the machine generated a leak related alarm because they were very engaged in caring for the patient.The customer did report that prior to use the a7 passed the recommended pre operative checkpoint list/tests.The customer directly attributed to the partial dislodge of the gauge that originated the leak to the reported event.During the reported event, the gauge was pushed back into its housing and the system operated normally.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported a leak coming from the paw gauge on the a7 anesthesia delivery system and that the patient was not properly ventilated or oxygenated for a period of 5 minutes.The patient coded and was defibrillated, no permanent sequels resulted and the patient did well post-operatively.The customer indicated that the paw gauge had become dislodged at some point during use and caused the leak.The customer could not recall if the machine generated a leak related alarm because they were very engaged in caring for the patient.The customer did report that prior to use the a7 passed the recommended pre operative checkout list/tests.The customer directly attributed to the partial dislodge of the gauge that originated the leak to the reported event.During the reported event, the gauge was pushed back into its housing and the system operated normally.

Manufacturer Narrative

On april 25, 2017, mindray field service representative visited the medical center again, and investigated the point of use of the specific a7 anesthesia machine as well as its surrounding area.During the on-site investigation, the biomed tech said there has been one staff cleaning all the rooms and devices, prior to the original report (mdr# 3007222337-2017-00003) and no one was aware that the paw gauge could be removed.(note: this paw gauge is not designed to be routinely removed.It is a redundant design as a backup pressure monitoring device in case the primary pressure sensor, which displays the pressure on a7's led screen, fails).If the surface of the a7 breathing system is cleaned and disinfected without due care, it is possible that the paw gauge is dislodged under excessive external force.During the onsite visit, mindray field service representative also found there have been many cables and tubing draped around the breathing system.These cables and tubes are connected to devices and patient on the surgical bed during the operation.Particularly, the tube of etco2 sample is connected to patient during the operation.If this tubing is wound around the paw gauge, and someone inadvertently pulled this tubing, the gauge could become dislodged.We are able to duplicate this in simulation tests.After this event, the medical center has streamlined responsibilities and the anesthesia tech is the only one that "turns over" the anesthesia system between cases.In addition, the anesthesia tech now checks that the paw gauge is fully inserted into the breathing system as part of his normal turn over process of the machine between cases.To date, this issue (paw gauge leaking or getting dislodged) has not reoccurred, according to the medical center.We also analyzed the gauge pointer issue reported in the complaint and found the pointer was off from the dial plate.The separation force of the pointer was measured and no discrepancy was detected.The detached indicator pointer issue is irrelevant to the leak problem, and the separation is very likely caused by excessive external force.It should be noted the paw gauge is a backup of the electronic pressure sensor, and by design, the user monitors the parameter on the led screen of the a7 anesthesia system.This is the first complaint about gauge pointer separation since the launch of a7 anesthesia system in us and out of us market.(b)(4).

• Brand Name: A7 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, shenzhen, 51810 8; CH 518108
• Manufacturer Contact: serena chen ; keji 12th road south; nanshan,; shenzhen, 51805-7 ; CH 518057
• MDR Report Key: 6278994
• MDR Text Key: 65803474
• Report Number: 3007222337-2017-00003
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151954
• 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,Followup,Followup
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A7 ANESTHESIA SYSTEM
• Device Catalogue Number: 0632F-PA00003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/30/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2016
• Date Manufacturer Received: 04/25/2017
• 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
• Patient Age: 76 YR
• Patient Weight: 94