MAUDE Adverse Event Report: MINDY.FABER@VYAIRE.COM VITAL SIGNS¿ ADULT/PEDIATRIC AIRWAY ADAPTER WITH DEHUMIDIFICATION TUBING; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	VITAL SIGNS¿ ADULT/PEDIATRIC AIRWAY ADAPTER WITH DEHUMIDIFICATION TUBING FOR CAP
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer has been requested to take pictures of the units in use and if there is an issue, to record of how frequent they have to change the suspect product.This is to identify if the problem is with the suspect product or with the co2 module provided by ge or if there was user error.It is indicated that the suspect product is available for evaluation.
Event or Problem Description
The customer reported that they frequently lose co2 waveform on their new ge dash monitoring system with the vital signs¿ adult/pediatric airway adapter with dehumidification tubing for capnoflex module.Initially, they felt the lines were blocked, but the same occurs even after training on proper use/position of the lines.They are changing the lines 3-5 times in a 12 hour shift.They are unable to pinpoint any specific action that causes the co2 line to stop reading.It did happen during patient use with no harm.There was an accompanying alarm, and the end user replaced the co2 line.However, there is concern over safety to both patient and end user as changing of lines equates to breaking of the circuit (possible loss of peep) and exposure in a covid-19 climate.
Additional Manufacturer Narrative
The issue is not reproducible.The visual inspection of the suspect product did not reveal any signs of damage or contamination.It was attached to the test loflo sensor for testing purposes.The unit did not produce any failures.The suspect product was tested with the test system and field return procedure, and no errors were produced.The unit operated as expected.

• Brand Name: VITAL SIGNS¿ ADULT/PEDIATRIC AIRWAY ADAPTER WITH DEHUMIDIFICATION TUBING
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MINDY.FABER@VYAIRE.COM; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): RESPIRONICS MEDICAL PRODUCTS (SHENZHEN) CO., LTD.; tang xia yong village; song gang twn, bao an dist.; shenzhen, 51810 5; CH 518105
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, CA 60045 ; 8333273284
• MDR Report Key: 10841487
• Report Number: 3003001596-2020-00001
• Device Sequence Number: 3732720
• Product Code: CCK
• UDI-Device Identifier: 10885403252723
• UDI-Public: (01)10885403252723(10)21032000
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS¿ ADULT/PEDIATRIC AIRWAY ADAPTER WITH DEHUMIDIFICATION TUBING FOR CAP
• Device Catalogue Number: 2013068-003
• Device Lot Number: 21032000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown