MAUDE Adverse Event Report: HILL-ROM CARE-E-VAC II; PUMP, PORTABLE, ASPIRATION

Model Number 753790

Device Problems Suction Problem (2170); Device Operates Differently Than Expected (2913)

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

Event Date 07/02/2017

Event Type  malfunction  

Event Description

During a rapid response, attempts were made to use the suction machine from the code cart.The suction provided was inadequate and supplies were obtained for the wall suction.Code completed with wall suction.

• Brand Name: CARE-E-VAC II
• Type of Device: PUMP, PORTABLE, ASPIRATION
• Manufacturer (Section D): HILL-ROM; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 6714193
• MDR Text Key: 80057769
• Report Number: 6714193
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 753790
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.; NOT APPLICABLE.
• Patient Age: 67 YR