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 F2 CIRCUIT D360-61 manufactured by King Systems.
[19588908]
Breathing bag is separating from bushing. No adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824226-2014-00006 |
| MDR Report Key | 4012372 |
| Report Source | 05 |
| Date Received | 2014-06-25 |
| Date of Report | 2014-06-19 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2013-06-27 |
| 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 F2 CIRCUIT |
| Generic Name | ANESTHESIA CIRCUIT |
| Product Code | OFP |
| Date Received | 2014-06-25 |
| Returned To Mfg | 2013-07-19 |
| Catalog Number | D360-61 |
| Lot Number | I15YJ |
| 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 | 2014-06-25 |