MAUDE Adverse Event Report: VYARIE MEDICAL VITAL SIGNS; VITAL SIGNS PEDIATRIC ANETHESIA BREATHING CIRCUIT

Model Number	1552017
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 8030673-2024-01032 for the second report refer to 8030673-2024-01033 for the third report.It was reported, the sampling port between the inspiratory and expiratory limbs detached easily during patient use; an unspecified non-serious injury was reported.The product was replaced.It was additionally reported, there was trouble ventilating a patient; however, the patient was not harmed, adjustments were made to compensate for the leaking circuit.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in process.All information reasonably known as of 24 oct 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med 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 sun med holdings llc.Sun med 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 sun med holdings complaint database and identified as (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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 8030673-2024-01032 for the second report.Refer to 8030673-2024-01033 for the third report.It was reported, the sampling port between the inspiratory and expiratory limbs detached easily during patient use; an unspecified non-serious injury was reported.The product was replaced.It was additionally reported, there was trouble ventilating a patient; however, the patient was not harmed, adjustments were made to compensate for the leaking circuit.
Additional Manufacturer Narrative
The device history record for lot 0004254036 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.The root cause could not be determined.All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med 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 sun med holdings llc.Sun med 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 sun med holdings complaint database and 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 an sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: VITAL SIGNS
• Common Device Name: VITAL SIGNS PEDIATRIC ANETHESIA BREATHING CIRCUIT
• Manufacturer (Section D): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mexico ; MX
• Manufacturer (Section G): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mexico ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20525188
• Report Number: 8030673-2024-01026
• Device Sequence Number: 8078324
• Product Code: CAI
• UDI-Device Identifier: 10190752118195
• UDI-Public: (01)10190752118195(10)0004254036(11)230707
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 1552017
• Device Lot Number: 1552017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2023
• 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
• Patient Sex: Unknown