MAUDE Adverse Event Report: WESTMED LLC CO2 EASY; PEDI CO2 EASY DETECTOR

Model Number	562135
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: co2.The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 15 nov 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and is identified as complaint - (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc.Product is defective or causes serious injury.
Event or Problem Description
During an intubation, the product failed twice, and we are not sure if we had a bad batch or if it was the size and condition of the patient (it was a micro-premie). .
Additional Manufacturer Narrative
H6: co2 the product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 15 nov 2024 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a sunmed holdings llc.Product is defective or causes serious injury.The complaint of "the product failed twice" regarding part 562135 was not confirmed.The root cause could possibly be a result of customer misuse.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 2 other complaints regarding a similar part and issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
During an intubation, the product failed twice, and we are not sure if we had a bad batch or if it was the size and condition of the patient (it was a micro-premie).

• Brand Name: CO2 EASY
• Common Device Name: PEDI CO2 EASY DETECTOR
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20700864
• Report Number: 2028807-2024-00069
• Device Sequence Number: 8101299
• Product Code: CCK
• UDI-Device Identifier: 00709078621352
• UDI-Public: (01)00709078621352(10)478158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 562135
• Device Catalogue Number: 562135
• Device Lot Number: 478158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown