MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..
[181789243]
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 no value (i. E. , actual: 113 ppm) was greater than the absolute max of 100 ppm for 12 consecutive seconds. Afterwards, a service log entry for failed low no cell calibration due to the low points being greater than the maximum value (max: 655 counts; actual value: 906 counts) was observed. 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 no sensor. As a result, the device's no sensor 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. A full functional test was performed and the device operated according to specifications. As a result, the device was placed back into circulation for customer use.
Patient Sequence No: 1, Text Type: N, H10
[181789244]
On (b)(6) 2019, a customer from the us called to report delivery stopped,failed no sensor, and sample line / filter block,high no - condition with inomax dsir plus (b)(4). Inomax dsir plus (b)(4) was removed from service and returned to the company for service evaluation. On 01-jan-2020, 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 followed by a failed low no cell calibration. This service log finding meets the criteria of a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004531588-2020-00009 |
| MDR Report Key | 9656085 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-11-25 |
| Date Mfgr Received | 2020-01-01 |
| Device Manufacturer Date | 2016-12-20 |
| Date Added to Maude | 2020-01-31 |
| 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 | 2020-01-31 |
| Returned To Mfg | 2019-12-13 |
| 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 | 2020-01-31 |