MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-13 for NEBULAE I 6-820-00 manufactured by Northgate Technologies Inc..
[179372827]
The warmer, nti part number 6-820-00; serial number (b)(4) arrived at nti on 1/30/2020 from (b)(4) distributor (b)(4). The unit was evaluated under nti capa (b)(4). During engineering inspection, the warmer was found to have experienced high heat as evidenced by the inside of housing fused together with the core. The backnutnut of the connecter was found to not be fully engaged onto the housing. The connector pins were found to be indexed one position axially, which, per capa (b)(4) (closed october 2018), causes the warmer to overheat and not display on-screen and no audible alert. Upon follow-up communication with the distributor in (b)(4), it was determined that the warmer had been autoclaved approximately 100 times, which is the defined life of the warmer according to the product requirement specification document (b)(4). The root cause is that connector was indexed in such a way which resulted in the device not showing the warmer icon and overheating with no audible alert. This root cause was identified in capa (b)(4) and corrective actions were taken on all product manufactured after closure of capa. The overtemperature event was not identified by the end user and was identified in a lab setting by the distributor. The device history record for (b)(4) from september of 2017 (manufacturing order (b)(4)) was reviewed and the device passed all testing. Nothing out of the ordinary was noted. The device has not been returned to nti for repair / evaluation previously. There have been no other complaints reported to nti for this device. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[179372828]
On 1/17/2020, northgate technologies was made aware of an issue with an in-line warmer from distributor (b)(4) in (b)(4) where it was alleged, "our customer couldn't use the product and asked us to check it. During our inspection, even though the warmer connected to nebulae i, the unit didn't display any thermometer symbol. And after that, the warmer heated and smoked with no alarm.... No adverse event and no delayed procedure... "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001450997-2020-00004 |
| MDR Report Key | 9708950 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2017-09-20 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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. TODD GATTO |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal | 60123 |
| Manufacturer Phone | 2248562250 |
| Manufacturer G1 | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Street | 1591 SCOTTSDALE COURT |
| Manufacturer City | ELGIN IL 60123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEBULAE I |
| Generic Name | INSUFFLATOR |
| Product Code | HIF |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 6-820-00 |
| Catalog Number | 6-820-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTHGATE TECHNOLOGIES INC. |
| Manufacturer Address | 1591 SCOTTSDALE COURT ELGIN IL 60123 US 60123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |