MAUDE Adverse Event Report: DORNOCH EVAC STATION; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULEV100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.Evaluated on site by external contractor.

Event Description

It was reported that the unit was not connecting to either cart and had an electrical burning smell.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for ultra evacuation unit serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On 16 january 2019, it was reported from (b)(6) that an evac was not connecting to either cart and it had an electrical burning smell.Bayside biomedical services inc.Was contacted about the evac and dispatched a service technician to be at the site.On (b)(6) 2019, the technician confirmed the reported event and replaced the unit¿s coupler (part #70027 and lot code #0029382), but the account called him back due to evac comm errors.He returned on (b)(6) 2019 and troubleshot the unit.He received many errors that were not consistent.In total, he noted intermittent evac comm errors as well as bleach and enzyme out errors.To resolve the bleach and enzyme errors, he would replace the enzyme tubing (part #91800), the bleach tubing (part #91476), the pickup straws (part #91557) as well as the bleach chemical valve (part #70094), the enzyme chemical valve (part #70095), and the chemical flow sensor (part #91220).He also replaced the coupler again (part #70027 and lot code #0029382) as well as the unit¿s main control board (part #91930).It is believed that the replacement main control board solved the communication error issue when the technician returned.He then verified that the device was functioning as intended and returned it to service without incident.The unit was tested, inspected, and repaired as per cl.Service work order (b)(4) on 16 january 2019.Based on the information available, the root cause for the unit not connecting to carts was due to a malfunctioning main control board.The main control board oversees all electrical function of the unit; a malfunctioning control board could deny the ability to connect to carts and make the unit issue communication errors, such as in the reported event.The malfunctioning control board could also be the source of the bleach and enzyme component issues experienced, as a bad board could essentially lose all electrical function in the evac, which would cause the cart to issue numerous errors when connected.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the enzyme and bleach tubing, enzyme and bleach chemical valves, chemical flow sensor, and pickup straws, as well as the coupler and main control board were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: EVAC STATION
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8325848
• MDR Text Key: 136144699
• Report Number: 0001954182-2019-00015
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULEV100
• Device Lot Number: 0019932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1