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| Model Number MODUEVO-ENERGY |
| Device Problems
Misconnection (1399); Connection Problem (2900)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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| Event Date 09/03/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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On (b)(6) 2020, getinge ssu(sales and service unit) in (b)(6) received a call from a hospital in (b)(6) regarding gas connection in or4.This hospital does not have any fixed co2 pipes in the house, but there is a co2 outlet in maquet medical ceiling supply unit- moduevo, and it's connected with a gas supply.The hospital wanted to know which type of gas was connected.On the same day, getinge fse(field service engineer) visited the hospital, checked and opened the ceiling, and found the co2 outlet was connected to the o2 gas supply.Fse observed the co2 outlet was sealed by the tape, and determined it's not checked and approved by the gas supplier.Therefore, he pointed it out to medical technician of hospital, and inform the medical staff that this outlet must not be used.Fse disconnected the gas pipeline, and removed the co2 outlet to avoid it's used by mistake.No any injury was involved and reported.On oct 19th., 2020, maquet suzhou, as the manufacturer of the medical ceiling supply unit, received the further information from getinge ssu with a notification letter from (b)(6)authority regarding the above issue.Then suzhou just realized that the co2 outlet with o2 gas supply was actually used in a laparoscopic cholecystectomy procedure on (b)(6) 2020, in that surgery an unexpected invasion of the gallbladder occurred when the surgeon activated the electrocautery.The surgeon reacted by interrupting the power supply to the electric cautery, and extinguishing the invasion with rinsing water.An intraoperative control showed that the patient didn't suffer any visible damage, and later, the patient was discharged as planned.As the manufacturer of medical ceiling supply unit, we realized it's an adverse event case therefore this initial report was established.This problem only occurred in (b)(6) so far.Since the similar products are sold to us market, this report is filed.
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Event Description
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(b)(6).This is an automated draft translation.If any uncertainty, contact the local ssu immediately; customer is still asking for technician today.
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Manufacturer Narrative
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Product introduction: the medical ceiling supply unit (model : moduevo )is made up of a number of modules that can be configured with one another.Depending on the modules used, medical ceiling supply units are designed for the following purposes: carrying and positioning of medical devices and monitors.Supply with mains voltage, compressed air and medical gases.Aspiration of anaesthesia gases and compressed air.In line with the intended purpose, moduevo is produced and assembled into the several modules such as beam, distributor at manufacturing site, distributed to the healthcare facility then installed together and connected with the gas supply and electricity of healthcare facility.The installation and connection is completed on site of healthcare facility.According to the fact that the gas hose of co2 in moduevo was wrongly connected to the o2 gas supply of healthcare facility for the incident in the hospital "(b)(6) ", maquet suzhou has performed the following investigation to figure out the possible root cause.1.Review the device history record and verify the gas pipeline within the concerned device as checked, one moduevo was installed in the hospital "(b)(6) ".This unit was produced in (b)(6) 2018, and installed at this hospital in (b)(6) 2018.The production history record for this concerned unit was reviewed, no any deviation is identified during the production process, and the unit has passed all the inspection and testing before release for shipment, which include all the tests on gas pipeline as following all types of gas outlets and labeling verified correct; color and marking of gas hoses verified correct; leakage and integrity tests passed.As further confirmation with the service manager of getinge ssu, the concerned unit is in good condition, the incorrect connection is not related with the quality of moduevo itself.2.Verify if the requirements in installation manual are clear and sufficient in order to ensure medical ceiling supply units could be installed and verified properly prior to putting into use, the installation manual is established and accompanied with the products to support the installation on site.The installation manual for moduevo (reference no.(b)(4)) was reviewed to verify if it provides the clear instruction for proper gas connection.In which the requirements are clearly defined as following.1)section 3 on page 24 states " gas hose connection must be carried out by a getinge qualified technician or a getinge-approved qualified technician.The technician must refer to the label attached on the gas hoses as well as the specific hose color to identify the gas type and then connect to matched gas risers to deliver the right gas to the corresponding outlet." the specific information and photo for gas hose and colors are also provided in the same page for following in execution.2)it is required to perform the gas checks after the gas pipeline connection is completed as the clear statement in section 5.8.1 on page 53.3)it is required to perform the gas checks and document the result per service protocol, as stated in section 20 on page 66.In summary, the installation manual has provided the clear and sufficient instructions for gas connection and verification.If all these requirements are fully followed, the incorrect connection could be avoided.3.Communication with service engineer to understand the details of installation as checked with service manager of getinge ssu in switzerland who was involved in the investigation on site, maquet suzhou collected the following information furtherly.1) the concerned moduevo was installed by mr.(b)(6).Who has been trained and qualified for maquet ceiling supply unit installation and service during 2018/01/09 ~ 2018/01/11.2) mr.(b)(6) is a experienced technician.He knows the process and requirements on gas connection quite well as confirmed, and he has installed the medical ceiling supply units for years, and there is no claim on those installed units in the past.3) mr.(b)(6) recalled he has checked the gas connections during the installation in the hospital "hirslanden andreas klinik", however, no documented evidence could be provided as the checklist used for installation is not updated to include the gas check requirements.4) complaint and service history records have been also checked to determine if this unit has been adjusted after installation, there is no record to show that it has been repaired or adjusted.According to the collected information with service manager, the possibility that the wrong connection by mistake during the installation couldn't be excluded.In addition, when the issue occurred, the co2 gas outlet was found putting with the tape which look like that the specific outlet was not permitted for use.It implies that this gas outlet was not fully verified and released for use.According to all the above investigation, it could be concluded this incident was very likely caused by incorrect connection during installation and the verification on gas connection was not fully executed due to the individual mistake.Remedial action: getinge field service engineer communicated with medical technician of hospital and informed the medical staff that this outlet must not be used.He furtherly disconnected the gas pipeline and removed the co2 outlet to avoid it's used by mistake.(done on (b)(6) 2020).Corrective action: 1.Installer mr.(b)(6) has been informed with this incident and he is aware of the mistake.He will be careful to follow the instructions strictly.(done on (b)(6) 2020) 2.Refresh the service qualification training to mr.(b)(6) (planned in q2, 2021.) 3.Require getinge ssu in switzerland to update installation checklist according to the provided installation manual to fully reflect the verification requirements.H3 other text : device not returned to manufacturer.
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Event Description
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On sept 3rd.,2020, getinge ssu(sales and service unit) in switzerland received a call from a hospital in switzerland regarding gas connection in or4.This hospital does not have any fixed co2 pipes in the house, but there is a co2 outlet in maquet medical ceiling supply unit- moduevo and it's connected with a gas supply.The hospital wanted to know which type of gas was connected.On the same day, getinge fse(field service engineer) visited the hospital, checked and opened the ceiling ,found the co2 outlet was connected to the o2 gas supply.Fse observed the co2 outlet was sealed by the tape and determined it's not checked and approved by the gas supplier , therefore he pointed it out to medical technician of hospital and inform the medical staff that this outlet must not be used.Fse disconnected the gas pipeline and removed the co2 outlet to avoid it's used by mistake.No any injury was involved and reported.On oct 19th., 2020, maquet suzhou, as the manufacturer of the medical ceiling supply unit, received the further information from getinge ssu with a notification letter from switzland authority regarding the above issue.Then suzhou just realized that the co2 outlet with o2 gas supply was actually used in an aparoscopic cholecystectomy procedure on (b)(6) , in that surgery an unexpected invasion of the gallbladder occurred when the surgeon activated the electrocautery.The surgeon reacted by interrupting the power supply to the electric cautery and extinguishing the invasion with rinsing water.An intraoperative control showed that the patient didn't suffer any visible damage and later the patient was discharged as planned.
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Search Alerts/Recalls
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