MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. (DORNOCH MEDICAL) ULEV100 EVAC STATION; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number UL-EV100

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

Docking station not working with three different machines, elbow clogged due to physician damage.Manufacturer response for ulev100 evac station, dornoch medical system (per site reporter).Repair by oem/vendor/depot, test and check/ operational.Replaced coupler, p.Stole tube and removed clog at elbow.

• Brand Name: ULEV100 EVAC STATION
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. (DORNOCH MEDICAL); 345 e main st; warsaw IN 46580
• MDR Report Key: 8503217
• MDR Text Key: 141580230
• Report Number: 8503217
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UL-EV100
• Device Catalogue Number: UL-EV100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1