MAUDE Adverse Event Report: Medline Medline; RESUSCITATOR, SMALL ADLT,MASK,BAG RES

Model Number	CPRM4416
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: Medline
• Common Device Name: RESUSCITATOR, SMALL ADLT,MASK,BAG RES
• Manufacturer (Section D): Medline; university of rochester medica; 5901 lac de ville blvd; rochester NY 14618
• 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: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; +1(616)259-8415
• MDR Report Key: 50744783
• Report Number: 1314417-2026-00058
• Device Sequence Number: 21424391
• Product Code: BTM
• UDI-Device Identifier: 10888277700482
• UDI-Public: (01)10888277700482
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: CPRM4416
• Device Catalogue Number: CPRM4416
• 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: 08/14/2026
• Initial Report FDA Received Date: 09/12/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown