MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE; ADULT RESUS BAG,TUBE,MANO,PEEP,FILT

Model Number	CPRM4426FPWM
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the resuscitation bag was leaking air, with the oxygen area intermittently popping off the back, resulting in inadequate oxygen delivery during resuscitation.The customer also reported that an unspecified injury occurred during the event; however, no additional details were provided.
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 in-progress.All information reasonably known as of 12 mar 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).This information is submitted pursuant to 21 cfr 803, 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 the resuscitation bag was leaking air, with the oxygen area intermittently popping off the back, resulting in inadequate oxygen delivery during resuscitation.The customer also reported that an unspecified injury occurred during the event; however, no additional details were provided.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.Correction: d9, h6.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 complaint history identified one additional complaint involving the same part number and a similar failure mode within the preceding 24 months.No additional trends were identified; monitoring will continue for any emerging trends.The device history record for lot 582867 was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 01 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 complaint- (b)(4).This information is submitted pursuant to 21 cfr 803, 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.

• Brand Name: MEDLINE
• Common Device Name: ADULT RESUS BAG,TUBE,MANO,PEEP,FILT
• 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: 24580889
• Report Number: 1314417-2026-00012
• Device Sequence Number: 10356036
• Product Code: BTM
• UDI-Device Identifier: 10197344100484
• UDI-Public: (01)10197344100484(10)582867(11)260107(17)310107
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/01/2026

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: CPRM4426FPWM
• Device Catalogue Number: CPRM4426FPWM
• Device Lot Number: 582867
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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