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

Model Number SC9200MBP-I

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

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

Event Date 05/21/2018

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-2145-2018) for patient port assembly separating.

Event Description

The customer alleges that " the elbow disconnected during use" no other details were provided and no patient injury/harm reported.

• Brand Name: STATCHECK
• 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: 7611018
• MDR Text Key: 111985307
• Report Number: 1314417-2018-00007
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC9200MBP-I
• Device Lot Number: 313447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• 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
• Removal/Correction Number: Z-2145-2018
• Patient Sequence Number: 1