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

Model Number CPRM1126

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

End user was able to return the affected device for evaluation.Product could not be fully evaluated, but investigator was able to confirm failure mode.Finished good device lot number was within the scope of recent recall (b)(4) for elbow disconnecting from patient port.

Event Description

The customer alleges that "the elbow broke during a code." no other details were provided.

• Brand Name: MEDLINE
• Type of Device: RESUS BAG
• 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: 7723807
• MDR Text Key: 115370301
• Report Number: 1314417-2018-00012
• 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
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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: 313176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1