MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; ADULT RESUS W/MASK, BAG RESERVOIR, FILTER & MANOMETER

Model Number	CPRM1116FM
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All information reasonably known as of 24 may 2024 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 known information 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 that was 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 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Event or Problem Description
Resuscitation bags that broke away from the bag part. .
Additional Manufacturer Narrative
All information reasonably known as of 24 may 2024 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 known information 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 that was 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 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint of "bag body broke away from the patient port" regarding part cprm1116fm was confirmed.The root cause could possibly be a result of the port not being fully inserted into the bag during assembly.A risk assessment was performed, and the ultimate risk was determined to be medium which does require reporting to the capa review board.There have been 0 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.
Event or Problem Description
Resuscitation bags that broke away from the bag part. .

• Brand Name: SUNMED LLC
• Common Device Name: ADULT RESUS W/MASK, BAG RESERVOIR, FILTER & MANOMETER
• 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: 19397864
• Report Number: 1314417-2024-00023
• Device Sequence Number: 20569484
• Product Code: BTM
• UDI-Device Identifier: 10888277628298
• UDI-Public: 10888277628298
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: CPRM1116FM
• Device Catalogue Number: CPRM1116FM
• Device Lot Number: 461276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/27/2024
• 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