MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-20 for INOMAX DS (DELIVERY SYSTEM) 10003 manufactured by Ino Therapeutics Llc/ikaria.
[878103]
A (b) (6) female was hospitalized and received inomax therapy via the inomax ds for pulmonary hypertension. On (b) (6) 2008, at 14:00 hours, a nurse walked by the patient and noticed a big x across the black screen (b) (4). The nurse called the respiratory therapist and the patient was manually ventilated when the machines were switched which took approximately 5 minutes. The arterial blood pressure of the patient dropped from 90mm/hg to 60mm/hg and continued to remain low. The reporter did not think that the patient experienced a decrease in oxygen saturation. At the time of this contact, the outcome of the event was unchanged. The reporter deemed the event related to the use of inotherapy. Follow up information was received on june 6, 2008. An 840 ventilator was used on the patient and the patient received 20 parts per million (ppm) of nitric oxide (no). The respiratory therapist reported prior to the device failure, the ventilator and calibration checks were performed with no errors. There was no nurse-patient contact prior to the event; the nurse was outside of the room. The respiratory therapist entered the patient's room when a drop in the blood pressure of the patient was observed and the device alarmed. The respiratory therapist observed a black screen on the device which alarmed "system failure. " she did not observed a black screen on the device which alarmed "sys failure. " she did not observe a big x across the screen as originally reported. The machine was then turned off and the patient was manually bagged while the machine was replaced. The respiratory therapist reported the patient recovered from the decrease in arterial blood pressure. The respiratory therapist provided the following ventilator settings: tidal volume: 600. Fraction of inspired oxygen (fio2) : 60%. Mode - assist control (ac) : 10. Breathing: 14 breaths per minute. Positive end expiratory pressure (peep): 5. The patient was treated with nitric oxide every 6 hours at 06:00/12:00/18:00. The respiratory therapist reported the patient was weaned to 10 ppm of nitric oxide then discontinued. The patient died approximately 2 weeks after the discontinuation of nitric oxide. The respiratory therapist deems the death not related to inotherapy or the decrease in blood pressure that occurred on (b) (6) 2008. The date and cause of death are unknown.
Patient Sequence No: 1, Text Type: D, B5
[7884568]
Med significant - clinically significant. The results of the device investigation revealed that an incorrect oxygen high calibration caused the displayed value to be 166% which resulted in a system shutdown alarm due to the user interface software, not being able to format the value. A new software (b) (4), which has been previously developed, will prevent the displayed oxygen value from being greater than 105%, thereby, preventing this anomaly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004531588-2008-00001 |
| MDR Report Key | 1074862 |
| Report Source | 05 |
| Date Received | 2008-06-20 |
| Date of Report | 2008-05-23 |
| Date of Event | 2008-05-20 |
| Date Mfgr Received | 2008-05-23 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-04-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY ANDERSON |
| Manufacturer Street | 6 STATE ROUTE 173 |
| Manufacturer City | CLINTON NJ 08809 |
| Manufacturer Country | US |
| Manufacturer Postal | 08809 |
| Manufacturer Phone | 9082386337 |
| Manufacturer G1 | INO THERAPEUTICS, LLC/IKARIA |
| Manufacturer Street | 2820 WALTON COMMONS WEST |
| 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 DS (DELIVERY SYSTEM) |
| Generic Name | APPARATUS, NITRIC OXIDE DELIVERY |
| Product Code | MRP |
| Date Received | 2008-06-20 |
| Returned To Mfg | 2008-05-27 |
| Model Number | 10003 |
| Catalog Number | 10003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INO THERAPEUTICS LLC/IKARIA |
| Manufacturer Address | MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-20 |