MAUDE Adverse Event Report: DORNOCH POWERED IV POLE - REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number UE514012000

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Customer has indicated that the product is in process of being evaluated by an external contractor and the investigation is in process.Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the cart was giving a burning smell.The event occurred prior to surgery.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).The previous repair record for intellicart system serial number 1580175 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.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On 10 june 2019, it was reported from (b)(6) asc that the cart was giving a burning smell.On 11 june 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site but could not confirm that there was a burning smell.The carbon filter was found to be a little loose, so the tech tightened the filter.The technician verified that the unit was functioning as intended then returned the unit to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac.Service work order (b)(4) on 10 june 2019.The reported event could not be confirmed during inspection of the device; therefore, the root cause for the unit giving a burning smell could not be determined.The device was noted to be functioning as intended and no problem was found.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information was received.

• Brand Name: POWERED IV POLE - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8686272
• MDR Text Key: 147589644
• Report Number: 0001954182-2019-00039
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• 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: 07/15/2019

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: UE514012000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 06/11/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1