MAUDE Adverse Event Report: COVIDIEN COVIDIEN; ANALYZER, GAS, CARBON DIOXIDE, GASEOUS PHASE

Model Number CS04178

Device Problems Material Discolored (1170); Smoking (1585); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Verified customer complaint of hot/smoking/odor.Unit was disassembled and visual inspection found that several components were thermally damaged.Battery pack was disassembled and visual inspection found no anomalies.Voltages and continuity for the battery pack and voltages for the power supply were checked.No issues were observed.A test board with filterline was connected to the power supply and powered up and passed post.Board was then connected to the battery pack and the battery pack was allowed to completely charge and discharge.No issues were observed during run.Root cause of the thermal damage is unknown.

Event Description

It was reported that when the customer put in a new battery pack, the unit would not work.The unit was then taken to biomed, and when turned on, two components turned red and started smoking.The smoke went into and discolored the display.There is no report of patient involvement associated with this event.

• Brand Name: COVIDIEN
• Type of Device: ANALYZER, GAS, CARBON DIOXIDE, GASEOUS PHASE
• Manufacturer (Section D): COVIDIEN; oridion medical ltd; p o box 45025; jerusulem 91450 ; IS 91450
• Manufacturer (Section G): COVIDIEN; oridion medical ltd; p o box 45025; jerusulem ; IS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5115778
• MDR Text Key: 27584427
• Report Number: 8044004-2015-00006
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS04178
• Device Catalogue Number: CS04178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1