MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-30 for INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..
[181787737]
Reportable malfunction with inomax dsir plus (b)(4) was documented and investigated under (b)(4). A review of the device's service log revealed that a delivery stopped alarm occurred as the monitored nitric oxide (no) value (i. E. , actual: 150 ppm) was greater than the absolute max of 100 ppm for 12 consecutive seconds. Prior to the delivery stopped, a service log entry for an injector module failure alarm was recorded as the analog injector readings were out of bounds (temp counts valid range: 70 to 4050 counts; actual temp counts: 7 counts). Although identified in the service log, the regional service center (rsc) did not experience a delivery stopped alarm during testing. The root cause for this occurrence was likely due to a malfunctioning injector module thermistor. As a result, the device's injector module was replaced. 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
[181787738]
On (b)(6) 2019, an internal employee performed a routine service log review for inomax dsir plus (b)(4) and discovered a delivery stopped alarm due to no greater than absolute max of 100 ppm preceeded by an injector module failure for no temp counts out of bounds. This service log finding meets the criteria of a reportable malfunction. This match was found during a routine review of the service log for a device located in the us. There was no reported complaint for the issue/alarm of delivery stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004531588-2020-00006 |
| MDR Report Key | 9649554 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2010-07-19 |
| Date Added to Maude | 2020-01-30 |
| 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 | MS. MEGAN VERNAK |
| Manufacturer Street | 1425 US ROUTE 206 |
| Manufacturer City | BEDMINSTER NJ 07921 |
| Manufacturer Country | US |
| Manufacturer Postal | 07921 |
| Manufacturer Phone | 9082386455 |
| 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 PLUS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS |
| Product Code | MRN |
| Date Received | 2020-01-30 |
| Returned To Mfg | 2019-12-09 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-01-30 |