MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; SMALL ADULT AIRFLOW W/MANOMETER

Model Number AF5140MB

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Could delay resuscitation of the patient.

Event Description

The end of the resuscitation bag popped off.

Manufacturer Narrative

Could delay resuscitation of the patient.The complaint of the end of the resuscitation bag popping off involving part af5140mb was confirmed.A root cause was determined to be the manual assembly operation was not conducted properly.A risk assessment was performed, and the ultimate risk was determined to be serious / capa optional, which does not require the initiation of a capa.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

Event Description

The end of the resuscitation bag popped off.

• Brand Name: SUNMED LLC
• Type of Device: SMALL ADULT AIRFLOW W/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: 18727884
• MDR Text Key: 336062717
• Report Number: 1314417-2024-00012
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10889483103012
• UDI-Public: 10889483103012
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF5140MB
• Device Catalogue Number: AF5140MB
• Device Lot Number: 462079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other