MAUDE Adverse Event Report: SUNMED Medline Industries, Inc.; RESUS BAG

Model Number CPRM1116

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

Customer returned affected device.Customer claim was confirmed through initial observations of returned device.Although the claim can be confirmed the failure mode and root cause is unknown at this time further investigation needed and a nonconformance has been opened to further investigate this defect.

Event Description

The customer alleges that " elbow broke off resus bag." no other details were provided and no patient injury/harm reported.

• Brand Name: Medline Industries, Inc.
• Type of Device: RESUS BAG
• Manufacturer (Section D): SUNMED; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer (Section G): VENTLAB; 2710 northridge dr. suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 7487810
• MDR Text Key: 107994791
• Report Number: 2246980-2018-00003
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1116
• Device Catalogue Number: CPRM1116
• Device Lot Number: 313297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1