MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-13 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[4819401]
Display issue - device screen was not functioning properly [device issue]. No adverse event [no adverse event]. Case description: upon internal review on (b)(6) 2014, it was determined this device complaint requires reporting. On (b)(6) 2014, a respiratory therapist (rt) called to speak with ikaria technical services regarding a device issue with inomax dsir ds20101099. The rt reported second hand that the device was not functioning properly. It was also reported that where the nitric oxide value was normally displayed was blacked out thereby making it impossible to read what concentration of nitric oxide the pt was receiving. It was stated that all other mentioned values were visible. The device has been removed from service and replaced with a backup device. The rt stated there was no pt injury or deterioration in a pt's health with the reported device issue. Inomax dsir ds20101099 was removed from service and returned to ikaria for service eval.
Patient Sequence No: 1, Text Type: D, B5
[12235788]
Upon internal review on (b)(4) 2014, it was determined this device complaint requires reporting ((b)(4)). Device investigation was completed on (b)(4) 2014. Case comment: on (b)(4) 2014: this device case did not result in an adverse event, however it is being reported because a similar device issue occurred in the past that resulted in a serious adverse event (refer to mdr #3004531588-2013-00023). Eval summary: inomax dsir ds20101099 was returned to the mfr for service investigation. The ikaria regional service center (rsc) reviewed the service log and confirmed the reported complaint-display goes blank. The service log revealed the delivery failure (df) alarms due to backlight current below minimum. (minimum: 800 counts actual value: 624 counts consistent with failing display). Rsc investigation did not reveal a blacked out area but did experience a pinkish/red color. The inverter board and the display were replaced. The root cause for this incident is display blank-backlight failure. This condition will be tracked and trended under ikaria's quality system. A full functional test was performed and the device operated according to specs so it was returned to the device service pool. This device case did not result in an adverse event, however it is being reported because a similar device issue occurred in the past that resulted in a serious adverse event (refer to mdr #3004531588-2013-00023).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2014-00024 |
| MDR Report Key | 3994782 |
| Report Source | 05 |
| Date Received | 2014-06-13 |
| Date of Report | 2014-03-04 |
| Date Mfgr Received | 2014-03-04 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2014-08-20 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIR REGULATORY |
| Manufacturer Street | 2902 DAIRY DR |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal | 53718 |
| Manufacturer Phone | 6083953910 |
| Manufacturer G1 | IKARIA |
| Manufacturer Street | 2902 DAIRY DR |
| 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, MITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2014-06-13 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-13 |