MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-02-06 for INOMAX DSIR (DELIVERY SYSTEM) 10007 manufactured by Ikaria.
[3286729]
Computer screen failed to analyze gas or allow changes to dose [device issue]. Case description: an initial medical device report, 2300460000-2012-8433, was received on (b)(4) 2013 from the fda. The medical device complaint was submitted from the office of clinical safety in a hospital in the united states. The complaint involved an inomax disr ((b)(4)) touch screen issue. Follow up information was obtained on (b)(6) 2013 and is included in this report. No medical history or demographics were provided for the patient. On (b)(6) 2012 a representative from the hospital's clinical safety office filed a voluntary report to the fda regarding a device brought to the biomedical department for inspection after a health care professional determined that the device was delivering nitric oxide (no) but the touch "computer screen filed to analyze the gases or allow the ability to change the dose. " the device had been on a patient, but there was no impact to the patient. The office of clinical safety confirmed that they investigated the complaint, tested the device and could not duplicate the problem. The device was put back into service by clinical safety. A search of the (b)(4) safety database and customer care database revealed no device reports received from this institution for this device or event. It was also confirmed that technical support services was not utilized for this complaint. (b)(4) requested that the device be returned for inspection, and the device was swapped out and returned to (b)(4) for further investigation on (b)(6) 2013.
Patient Sequence No: 1, Text Type: D, B5
[10472696]
On (b)(4) 2013 a user mdr 2300460000-2012-8433 was received by (b)(4) via the fda. The touchscreen for inomax dsir device # (b)(4) "failed to analyze the gases or allow the ability to change the dose. " evaluation summary: follow receipt of a user mdr from cdrh, the device was swapped out at the user facility and returned to the manufacturer for service investigation. (b)(4) had not previously received a copy of the user mdr. On inspection, the device did not exhibit the symptoms reported by the user however, it did not pass all touchscreen tests. This touchscreen was replaced and a full functional test was performed. The device passed all tests in accordance with specifications and was returned to the device pool for distribution. The root cause for the reported malfunction was a high resistance connection in a conductor associated with the touchscreen, causing intermittent touchscreen responsiveness. As a result of a prior investigation, (b)(4) had initiated a touchscreen test intended to identify devices which could exhibit intermittent responsiveness. Supplier corrective action has been initiated and (b)(4) will continue to monitor and track complaints to identify any further actions that may be required. It should be noted that the initial occurrence of touch screen unresponsiveness did not result in any effect of the patient undergoing treatment at the time and the affected device was replaced by a different device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2013-00002 |
| MDR Report Key | 2950286 |
| Report Source | 99 |
| Date Received | 2013-02-06 |
| Date of Report | 2013-01-08 |
| Date Mfgr Received | 2013-01-08 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2013-04-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID TRUEBLOOD, DIRECTOR |
| 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, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2013-02-06 |
| Model Number | 10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-02-06 |