MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. MEDLINE; ANESTHESIA MASK

Model Number DYNJAAMASK3

Device Problem Break (1069)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

The customer complaint is confirmed and the four (4) returned lots are affected: lot #: 40019030117, lot#: 40019030108, lot#: 40019030103, lot#: 40019030104.Review of inventory and product retains has narrowed the scope to the four (4) above noted lot numbers.All four (4) affected lots are for the same part # which is dynjaamask3.A corrective preventive action has been initiated.

Event Description

The customer alleges that " anesthesia mask falling apart." no other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: ANESTHESIA MASK
• 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: 8898410
• MDR Text Key: 191468429
• Report Number: 1314417-2019-00041
• Device Sequence Number: 1
• Product Code: BSJ
• 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: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJAAMASK3
• Device Lot Number: 400119030117
• Type of Device Usage: N
• Patient Sequence Number: 1