MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-22 for INOMAX DSIR (DELIVERY SYSTEM) 10071 manufactured by Mallinckrodt Manufacturing Llc.
[181373893]
Reportable malfunction with inomax dsir dg20150119 was documented and investigated under (b)(4). A review of the device's service log revealed that a delivery failure alarm occurred due to over-delivery of nitric oxide for 12 consecutive seconds on 16-aug-2019. The root cause for this occurrence was likely due to a malfunctioning proportional valve. As a result, it was recommended to the distributor to replace the proportional valve. This condition will be tracked and trended under the company's quality system. Trends were reviewed for this reportable condition and determined to be within the established control limits. No further action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[181373894]
On (b)(6) 2019, a mallinckrodt internal employee discovered a delivery failure alarm due overdelivery for inomax dsir dg20150119. This service log finding meets the criteria of a reportable malfunction. There was no complaint alleged against this device. This match was found during routine review of service logs from a device in the (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004531588-2020-00016 |
| MDR Report Key | 9618235 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2019-08-16 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2015-05-14 |
| Date Added to Maude | 2020-01-22 |
| 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 | MEGAN VERNAK |
| Manufacturer Street | 1425 US ROUTE 206 |
| Manufacturer City | BEDMINSTER NJ 07921 |
| Manufacturer Country | US |
| Manufacturer Postal | 07921 |
| Manufacturer G1 | MALLINCKRODT MANUFACTURING LLC |
| Manufacturer Street | 6603 FEMRITE DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOMAX DSIR (DELIVERY SYSTEM) |
| Generic Name | APPARATUS |
| Product Code | MRN |
| Date Received | 2020-01-22 |
| Model Number | 10071 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MANUFACTURING LLC |
| Manufacturer Address | 6603 FEMRITE DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-22 |