MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-15 for INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..
[180829983]
Reportable malfunction with inomax dsir plus ds20160245 was documented and investigated under (b)(4). The device was returned to a regional service center (rsc) for evaluation. A review of the device's service log revealed that a low no alarm occurred in conjunction with zero flow measured by the connected injector module (im). Testing of the returned device did not reproduce the low no alarm observed in the device's service log. Further inspection of the returned device identified that pin 6 of the dsir plus head's im cable receptacle were damaged. The root cause for the low no alarm was due to the damaged im cable receptacle pins. As a result, the device's im cable receptacle 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
[180829984]
On (b)(6) 2019, a customer from the us called to report physical damage to the injector module (im) receptacle with inomax dsir plus ds20160245. Inomax dsir plus ds20160245 was removed from service and returned to the company for service evaluation. On 16-dec-2019, an internal employee performed a service order review for inomax dsir plus ds20160245 and discovered a damage im receptacle pin 6 and a low no alarm with 0 im flow in the service log. This finding meets the criteria of a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004531588-2020-00001 |
| MDR Report Key | 9593498 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-10-06 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Returned To Mfg | 2019-12-08 |
| 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 | 2020-01-15 |