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

Model Number CPRM1116M

Device Problem Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

The customer alleges that "the port on the mask is deformed/warped." no other details were provided and no patient injury/harm reported.Affected product was not returned but a photo of the defective product was provided.The investigator was able to confirm the customer claim by studying the photograph.

Event Description

The customer alleges that "the port on the mask is deformed/warped." 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: 7890154
• MDR Text Key: 120834292
• Report Number: 1314417-2018-00031
• 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: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• 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: 314461
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1