MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was evaluated by an external contractor.The previous work order in customer relationship management (crm) for ultra duo flex fluid cart 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 work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired two times, the previous repair being for an issue with the cl500 housing on 09 november 2016.The cl500 housing is not associated with the current repair.Thus, this repair was a non-related issue.On (b)(6) 2018, it was reported from (b)(6) that a unit will at times indicate full when it is empty and a pm timer warning populates even though the unit was recently pm'ed.On (b)(6) 2018, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to confirm that the cart was reading full when it was empty, but noted tandem warnings on cylinder 1.He replaced the cylinder 1 level sensor (part # 81584, lot code 0027381), reset the pm timer, and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.Service work order (b)(4) on (b)(6) 2018.The reported event of the unit reading full when empty was never confirmed during inspection of the device.Therefore the root cause of the unit reading full when empty could not be determined.The reported event of the unit issuing pm timer warnings was confirmed during inspection of the device, however it cannot be determined from the information provided what caused the pm timer to populate.Therefore the root cause of the unit issuing pm timer warnings could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that unit will at times indicated full when it is empty.The pm timing warning populates as well.The event timing was during cleaning.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7554142
• MDR Text Key: 109762391
• Report Number: 0001954182-2018-00033
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

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 Model Number: N/A
• Device Catalogue Number: ULDU500R
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1