MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-31 for INO THERAPEUTICS, INC UNK manufactured by Ino Therapeutics, Inc.
[745922]
Patient was admitted to the hosp via the emergency dept in 2006 for hypoxia and syncope following a 3 day onset of flu diagnosed by his physician. Patient's worsening condition in the emergency dept required intubation during which time he had a cardiopulmonary arrest. Patient was successfully resuscitated and admitted to icu intubated. Patient was placed on a ino therapeutics machine for nitric oxide treatment in 2006. Two weeks later, the ino therapeutics machine malfunctioned and the pt's oxygen saturations dropped to 79%. The respiratory staff had to bypass the system so pt could continue to receive nitric oxide in combination with oxygen. Patient's condition remains the same, as it did prior to this event. Patient remains intubated. Patient was placed on another ino therapeutics nitrics oxide delivery machine. On the same day, patient was receiving nitric oxide 1 part per million. Patient, during hospitalization, rec'd as much as 3 parts per million of nitric oxide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 977270 |
| MDR Report Key | 977270 |
| Date Received | 2006-03-31 |
| Date of Report | 2006-02-28 |
| Date of Event | 2006-02-27 |
| Date Facility Aware | 2006-02-27 |
| Report Date | 2006-02-28 |
| Date Reported to Mfgr | 2006-02-28 |
| Date Added to Maude | 2008-01-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INO THERAPEUTICS, INC |
| Generic Name | INO THERAPEUTICS NITRIC OXIDE DELIVERY SYST. |
| Product Code | CBR |
| Date Received | 2006-03-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 5JP04406 |
| ID Number | TL02050612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 945411 |
| Manufacturer | INO THERAPEUTICS, INC |
| Manufacturer Address | 6 STATE ROUTE 173 CLINTON NJ 08809 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-03-31 |