MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for TCM COMBIM 903-111 manufactured by Radiometer Medical Aps.
[33923791]
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.
Patient Sequence No: 1, Text Type: N, H10
[33923792]
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.
Patient Sequence No: 1, Text Type: D, B5
[69470993]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2015-00035 |
| MDR Report Key | 5285712 |
| Date Received | 2015-12-10 |
| Date of Report | 2017-03-09 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2013-06-19 |
| Date Added to Maude | 2015-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOM ENGDAHL |
| Manufacturer City | BR 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer Phone | 538273827 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer City | BR 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM COMBIM |
| Generic Name | TCM COMBIM MONITORING SYSTEM |
| Product Code | LKD |
| Date Received | 2015-12-10 |
| Model Number | 903-111 |
| Catalog Number | 903-111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | ?KANDEVEJ 21 BR?NSH?J, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-10 |