MAUDE Adverse Event Report: VYARIE MEDICAL AIRLIFE; AIRLIFE ADULT MANUAL RESUSCITATOR OXYGEN RESERVOIR BAG, PEEP VALVE, WITHOUT MASK

Model Number	2K8033
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Hypoxia (1918); Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 06 aug 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 8030673-2024-01011 for the first report fda user facility mw report mw mw5156100 reported, "during endoscopy, patient became hypoxic and [the] ambubag was used to bag valve mask patient, but despite good chest rise and positive end tidal carbon dioxide, patient remained hypoxic.When [the] provider realized [the] reservoir bag was not fully inflating, different brand ambubag used and patient's hypoxia immediately resolved.During the defective device use, [the] patient's saturations dropped as low as 40%.".
Additional Manufacturer Narrative
The device history record for lot 0004265545 was reviewed and the product was produced according to product specifications.Without a sample to perform functional evaluation the root cause cannot be determined.All information reasonably known as of 25 sep 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.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 8030673-2024-01011 for the first report.Fda user facility mw report mw mw5156100 reported, "during endoscopy, patient became hypoxic and [the] ambubag was used to bag valve mask patient, but despite good chest rise and positive end tidal carbon dioxide, patient remained hypoxic.When [the] provider realized [the] reservoir bag was not fully inflating, different brand ambubag used and patient's hypoxia immediately resolved.During the defective device use, [the] patient's saturations dropped as low as 40%." the patient's current condition was not reported.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE ADULT MANUAL RESUSCITATOR OXYGEN RESERVOIR BAG, PEEP VALVE, WITHOUT MASK
• Manufacturer (Section D): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 19918978
• Report Number: 8030673-2024-01016
• Device Sequence Number: 8178088
• Product Code: OFP
• UDI-Device Identifier: 10190752114364
• UDI-Public: (01)10190752114364(10)0004265545(17)251128
• Combination Product (Y/N): N
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Expiration Date: 11/28/2025
• Device Model Number: 2K8033
• Device Catalogue Number: 0004265545
• Device Lot Number: 0004265545
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/25/2024
• 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; Required Intervention
• Patient Sex: Unknown