MAUDE Adverse Event Report: MEDLINE INDUSTRIES UNKNOWN

Model Number	UNKNOWN
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a neonatal patient in the icu experienced a deterioration in vital signs, prompting the care team to initiate manual ventilation.When the manual resuscitation bag was squeezed, the pressure manometer did not move, and the care team was unsure whether effective breaths were being delivered, as chest rise was difficult to assess.It was later determined that the endotracheal tube had become displaced prior to manual ventilation.A new manual resuscitation bag was obtained and placed into use, and the patient's endotracheal tube was removed and replaced.Following these interventions, the patient's vital signs normalized and the patient's condition improved.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.The product involved in the report has not been returned.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 28 apr 2026 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 airlife represents all of the information known 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 airlife.Airlife has no independent knowledge of the event reported but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint- (b)(4).Device reporting requirement, and should not be considered to be an admission that an airlife product is defective, caused, or contributed to a serious injury.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.The product associated with the complaint was not returned for evaluation, and no photographic or videographic evidence was provided.In the absence of visual documentation, the complaint could not be confirmed; furthermore, without a sample for functional testing, the root cause could not be determined.A review of the device history record is not possible as no lot number was provided.The documented udi is based on the stock/product code provided by the reporter; the udi-pi is not available as no lot number was provided.All information reasonably known as of 27 may 2026 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 airlife represents all of the information known 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 airlife.Airlife has no independent knowledge of the event reported, but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the airlife 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 airlife product is defective, caused, or contributed to a serious injury.
Event or Problem Description
It was reported that a neonatal patient in the icu experienced a deterioration in vital signs, prompting the care team to initiate manual ventilation.When the manual resuscitation bag was squeezed, the pressure manometer did not move, and the care team was unsure whether effective breaths were being delivered, as chest rise was difficult to assess.It was later determined that the endotracheal tube had become displaced prior to manual ventilation.A new manual resuscitation bag was obtained and placed into use, and the patient's endotracheal tube was removed and replaced.Following these interventions, the patient's vital signs normalized and the patient's condition improved.

• Brand Name: UNKNOWN
• Common Device Name: UNKNOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES; 3 three lakes dr; northfield IL 60093
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no. 85 parque indust. mexicali; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 25029099
• Report Number: 1314417-2026-00027
• Device Sequence Number: 18707241
• Product Code: BTM
• UDI-Device Identifier: 10197344100484
• UDI-Public: (01)10197344100484
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown