MAUDE Adverse Event Report: SUNMED HOLDINGS LLC MEDLINE; ADULT RESUS W/MASK AND BAG RESERVOIR

Model Number	CPRM1116
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manual resuscitator inability to inflate would delay the resuscitation of patient.
Event or Problem Description
Not inflating. .
Additional Manufacturer Narrative
The manual resuscitator inability to inflate would delay the resuscitation of patient.The complaint of "not inflating" regarding part cprm1116 was not confirmed.The root cause cannot be determined but could possibly be a result of "mfg error - connection to squeeze bag leaks".A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been 0 other complaints were regarding the same part and a similar issue within the 24 months preceding this complaint.No response was requested from the customer.
Event or Problem Description
Not inflating. .

• Brand Name: MEDLINE
• Common Device Name: ADULT RESUS W/MASK AND BAG RESERVOIR
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18628109
• Report Number: 1314417-2024-00009
• Device Sequence Number: 8042321
• Product Code: BTM
• UDI-Device Identifier: 10884389125120
• UDI-Public: 10884389125120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: CPRM1116
• Device Catalogue Number: CPRM1116
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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
• Patient Sex: Unknown