MAUDE Adverse Event Report: RADIOMETER MEDICAL APS TCM COMBIM; TCM COMBIM MONITORING SYSTEM

Model Number 903-111

Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Manufacturer Narrative

By replacing the tcm base unit and the module with a newer module (above run 0173) the problem was solved.The root cause to this problem has been identified to be identical to the root cause to a previous problem which was causing the error message "sound hardware corrupted".This issue was solved for combim modules from run (b)(4) and onwards and (b)(4).On very rare occasions this problem may also cause the too high alarm signal.A health risk assessment has been prepared on this issue with the following conclusion: "it is considered not likely that the described error will lead to any adverse health consequences for the exposed patients besides inconvenience or temporary discomfort." radiometer has initiated a class iii recall in order to inform the customers about the problem.The customers are informed that if they experience that the alarm sound is higher than the pre-set volume, they should immediately contact the local radiometer service representative, whom will take action to solve this issue permanently.

Event Description

The customer reports that after running without any problem and with volume control set to 1 the analyzer gives an alarm which is significantly louder than the highest possible analyzer volume.According to the instructions for use, the alarm sound pressure at the highest alarm sound level is 83 dba.After shutting down and restarting the analyzer the problem did not appear again.The customer reports that 10-15 incidents regarding significantly louder volume happened in 2013.The customer is using 4 tcm combim systems and the problem concerns all four analyzers.Only the serial number for one of the analyzers is known.The incident happened in 2014 but at that time the incident was not assessed as a potential health hazard and thus not reported.Radiometer has recently received new information regarding this issue and based on that the assessment has been changed.No maltreatment, injury or death has been reported related to this event.

• Brand Name: TCM COMBIM
• Type of Device: TCM COMBIM MONITORING SYSTEM
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; åkandevej 21; brønshøj, 2700 ; DA 2700 ; 538273827
• MDR Report Key: 5285712
• MDR Text Key: 33923791
• Report Number: 3002807968-2015-00035
• Device Sequence Number: 1
• Product Code: LKD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 903-111
• Device Catalogue Number: 903-111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2013
• 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