MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record (dhr) review for intellicart fluid system serial (b)(4), noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On (b)(6) 2017, it was reported from (b)(6) hospital that the unit having crackling noise , when the cart was turned on and monitor was comes on intermittently.The service company was contacted about the cart and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found that the power supply switch on/ off intermittent, shorting sound when switched from on/off and also burn odor from switch.The technician replaced power inlet module (part#90204) 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.Service work order (b)(4) on (b)(6) 2017.The root cause of the reported was due to a power inlet module malfunction.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet module was replaced.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 the unit had crackling noise when cart is turned on and the monitor comes on intermittently.The event occurred prior to use.No adverse events were reported as a result of this malfunction.Investigation revealed there was a shorting sound when switched from on/off and also burn odor from switch.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7063105
• MDR Text Key: 93606940
• Report Number: 0001526350-2017-00897
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P K162421
• 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: 11/28/2017

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: 00514010200
• Device Lot Number: 0024393
• Other Device ID Number: (01)00889024466005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1