MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. RESUCUMED; RESUS BAG

Model Number BVMB510S-F

Device Problem Component Missing (2306)

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

Event Date 02/10/2019

Event Type  malfunction  

Manufacturer Narrative

No product was returned.Batch record review was performed and operator interview confirmed that procedure for assembling and packaging was followed.An inventory evaluation of the same part number had masks included as expected.The investigation is inconclusive.

Event Description

The customer alleges that "resus bag is missing the mask".No other details were provided and no patient injury/harm reported.

• Brand Name: RESUCUMED
• Type of Device: RESUS BAG
• 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: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 8411728
• MDR Text Key: 139190867
• Report Number: 1314417-2019-00008
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BVMB510S-F
• Device Lot Number: 317003
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other