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

Model Number CPRM1126

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

The affected device was returned and the defect was confirmed.The affected device falls within the scope of recall (z-2152-2018) for patient port assembly separating.

Event Description

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

Manufacturer Narrative

When claim was initially reported the end user stated the lot number was 313176, this lot number was in the recall scope.When the complaint questionnaire was returned the reported lot number was 309617, the new lot number provided was not within the scope of recall.An inventory evaluation was performed, product was visually inspected and functionally tested for the seating of the c-ring and elbow subassembly.No abnormalities or discrepancies found during evaluation.The end user did not send affected device back for evaluation.There were several attempts to obtain affected device to perform an evaluation, but none were effective.

Event Description

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

• Brand Name: MEDLINE
• Type of Device: RESUS BAG
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• MDR Report Key: 7629044
• MDR Text Key: 112048841
• Report Number: 1314417-2018-00009
• 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
• Source Type: distributor
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1126
• Device Catalogue Number: CPRM1126
• Device Lot Number: 309617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Removal/Correction Number: Z-2152-2018
• Patient Sequence Number: 1