MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC. AIRFLOW; MANUAL RESUSCITATOR

Model Number AF5140MB

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned, the lot number provided by the customer, 0004020695, is invalid and can not be tracked back to sunmed ap or sunmed gr, thus batch record review is not possible.Engineering visually inspected (qty 20) bags of af5140mb from lot # 319551 to verify that the mask was included in the bag.All (qty 20) bags of af5140mb had the mask included in the bag.The investigation is inconclusive.

Event Description

The customer alleges that "no mask in the bag that contains the resuscitator." no other details were provided and no patient injury/harm reported.

• Brand Name: AIRFLOW
• Type of Device: MANUAL RESUSCITATOR
• Manufacturer (Section G): SUNMED HOLDINGS, LLC.; 2710 northridge dr. nw.; suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 8955454
• MDR Text Key: 191468748
• Report Number: 1314417-2019-00048
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF5140MB
• Device Lot Number: 00204020695
• Type of Device Usage: N
• Patient Sequence Number: 1