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

Model Number CPRM1116M

Device Problem Break (1069)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to evaluate as well as photographs and both sources of evidence confirm the complaint.A nonconformance has been opened to further investigate this product.

Event Description

The customer alleges that " the connector that holds the mask onto the bag snapped off inside mask while intubating." no other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: MANUAL RESUSCITATOR
• 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: 9554844
• MDR Text Key: 196233510
• Report Number: 1314417-2020-00001
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1116M
• Device Lot Number: 318973
• Type of Device Usage: N
• Patient Sequence Number: 1