MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-09 for TCM COMBIM 903-111 manufactured by Radiometer Medical Aps.
[28377173]
The analyzer has been taken to radiometer's workshop for further investigation. Up to now the problem has not been reproduced.
Patient Sequence No: 1, Text Type: N, H10
[28377174]
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. According to our information the monitor was placed in a neonatal ward.
Patient Sequence No: 1, Text Type: D, B5
[32703066]
By replacing the module with a newer module (above run 0173) the problem was solved. The root cause to this problem was found 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 0174 and onwards and implemented in production in (b)(6) 2014. 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 with radiometer ref. Fan 915-343 in order to inform all customers with a combim module below run 0174 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
[42979463]
On (b)(6) 2016 a second revision of the recall with radiometer ref. Fan (b)(4) was issued. All the potentially affected tcm combim modules at customer sites will be updated. Fda is currently assessing the classification of the recall. Please refer to crr 3002807968-03/08/16-001-c for further details.
Patient Sequence No: 1, Text Type: N, H10
[69361182]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807968-2015-00023 |
| MDR Report Key | 5140007 |
| Date Received | 2015-10-09 |
| Date of Report | 2017-03-08 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2009-12-22 |
| Date Added to Maude | 2015-10-09 |
| 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 | 2015-10-09 |
| Returned To Mfg | 2015-01-01 |
| Model Number | 903-111 |
| Catalog Number | 903-111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-10-09 |