MAUDE Adverse Event Report: ORIDION MEDICAL MICROSTREAM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	CS08651-02
Medical Device Problem Codes	Device Alarm System (1012); Failure to Power Up (1476); Filtration Problem (2941)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the device which is used for nurse's call had an unwavering spo2 alarm when the patient desaturated.It was also observed that the device was found to be not working, turned on and off and generated an alarm of filter line not connected.The patient's death was covid-related.
Additional Manufacturer Narrative
Additional info: b5, g4, h1(malfunction) medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Visual inspection noted that unit was returned without a battery.The alternating current (ac) power was connected.The ir and red leds (infrared light-emitting diode) were observed to flicker.There were no readings given by the device.Functionally, the device was reconnected several times with the same result.Rear housing was removed.Inspection of the printed circuit board assembly (pcba) found insufficient solder on the wire connections for component l6.The solder was repaired.Unit began to give readings.Spo2 was changed between 75 and 90 several times.The device was disconnected.The nurse call and audible/visual alarms functioned normally.The pcba was removed and retained.It was reported that the device had unweaving alarm and was not working.An associated device issue was confirmed.The most likely root cause was component issue.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the device which is used for nurse's call had an unwavering spo2 alarm when the patient desaturated.The device was found to be not working, turned on and off and generated an alarm of filter line not connected.The hospital cannot verify that the device in this report had the nurse call feature enabled and was turned on.Any nurse call setting were lost when the biomed department used this device after it was obtained and all information from the event was erased.The hospital reported the patient's death is covid19 related and the device was not related to the death in any way.

• Brand Name: MICROSTREAM
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• MDR Report Key: 10068534
• Report Number: 8044004-2020-00003
• Device Sequence Number: 14376703
• Product Code: CCK
• UDI-Device Identifier: 10884521551480
• UDI-Public: 10884521551480
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K112368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: CS08651-02
• Device Catalogue Number: CS08651-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 07/02/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/23/2020; 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention