MAUDE Adverse Event Report: MEDLINE INDUSTRIES MEDLINE; RESUSCITATOR, SMALL ADULT, BAG RES, PEEP, MANO

Model Number	CPRM4416FPM
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
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 07 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 (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.
Additional Manufacturer Narrative
H6: 4756 (appropriate impact term/code not available): manual resuscitation bag.The complaint product was returned to the supplier for evaluation.Functional testing was performed on the returned product (lot 555593).Test results demonstrated that the sampled devices met the requirements of iso 10651 4:2023 for oxygen delivery and minimum tidal volume.The reported issue could not be confirmed.A review of complaint history identified no additional complaints involving the same part number or similar failure modes within the preceding 24 months.No trends were identified; ongoing monitoring will continue for any emerging trends.The device history record for lot 555593 was reviewed and confirmed that the product was manufactured in accordance with specifications.All information reasonably known as of 15 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 (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.

• Brand Name: MEDLINE
• Common Device Name: RESUSCITATOR, SMALL ADULT, BAG RES, PEEP, MANO
• 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: 24539797
• Report Number: 1314417-2026-00011
• Device Sequence Number: 18734873
• Product Code: BTM
• UDI-Device Identifier: 10193489019049
• UDI-Public: (01)10193489019049(10)555593(17)300504(11)250504
• 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): 04/15/2026

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: CPRM4416FPM
• Device Catalogue Number: CPRM4416FPM
• Device Lot Number: 555593, 581139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2025
• 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