MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-25 for UNIVERSAL FLEX2 CIRCUIT KNCF476-6121Z manufactured by King Systems.
[17297260]
Anesthesiologist noted co2 levels were not normal during anesthesia. Another anesthesia machine was used but did not correct the issue. It was noticed that the inner tube of the coaxial circuit had disconnected from the connector. The anesthesia circuit was replaced and the issue resolved. The case was delayed as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824226-2014-00007 |
| MDR Report Key | 4012371 |
| Report Source | 05 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-19 |
| Date of Event | 2012-02-13 |
| Date Mfgr Received | 2012-02-13 |
| Date Added to Maude | 2014-08-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 15011 HERRIMAN BLVD. |
| Manufacturer City | NOBLESVILLE IN 46060 |
| Manufacturer Country | US |
| Manufacturer Postal | 46060 |
| Manufacturer Phone | 3177766823 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL FLEX2 CIRCUIT |
| Generic Name | ANESTHESIA CIRCUIT |
| Product Code | OFP |
| Date Received | 2014-06-25 |
| Returned To Mfg | 2012-02-17 |
| Catalog Number | KNCF476-6121Z |
| Lot Number | IZDZ5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS |
| Manufacturer Address | NOBLESVILLE IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-25 |