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

Model Number PM35MN02

Device Problem Material Integrity Problem (2978)

Patient Problem Cyanosis (1798)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the patient was desaturated to 54% for 3 minutes and the device did not alarm.It was also stated that the device was previously shown a white screen and power cycled by itself causing to be disconnected from vital sync not to be alarmed also.The patient looked blue or cyanotic when found out.

Manufacturer Narrative

Additional info: date received by mfr, device evaluated by mfr, evaluation codes.Evaluation summary: one sample was received for evaluation.No fault was found in the monitor operation.The alarms were set to disable and thus did not provide the notification during the event.The monitor has shown to be operating correctly under the alarm settings that have been set through the institutional defaults.The monitor is recording the trends and providing information on saturation and pulse rate as expected.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.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.

• Brand Name: MICROSTREAM
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer (Section G): ORIDION MEDICAL; 7 hamarpeh st.; jerusalem 91235
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8456510
• MDR Text Key: 140012921
• Report Number: 8044004-2019-00007
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 10884521551596
• UDI-Public: 10884521551596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM35MN02
• Device Catalogue Number: PM35MN02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 6 YR
• Patient Weight: 25