MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-09-03 for AMICO CORP MICROPROCESSOR BASED DIGITAL MANIFOLD ALERT-2 M2LT-D-HH-U-AIR * manufactured by Amico Corp..
[303853]
Pt was transferred to this facility from tertiary care icu for ongoing care. Pt receiving 28% blended oxygen. This facility has a two manifold bank system for medical air. Each bank consists of four h tanks of medical air, when one bank is in use the other sits in reserve. As soon as the bank in use is depleted the system automatically switches to the reserve bank and the empty tanks are replaced. Medical air alarms began sounding-left bank reading empty, right bank reading low pressure. Previous pressure readings indicated sufficient quantity of medical air. System assessed-no line leaks found, depleted bank tanks replaced. Two days later the same incident occurred-one bank depleted, one bank low. Again, no line leaks found. Tanks switched out. Investigation of incidents continued with assessment of blender in use. Found that the blender was not a low flow blender. Set up switched to low flow blender. While the blender that was in use would use more medical air than a low flow blender this would not account for the significant loss of medical air that was experienced. Ongoing investigation into the manifold system found that the pressure line was giving a false pressure reading. When one bank depletes and the system automatically switches over the empty bank started pressurizing again. The pressure line contains a shuttle valve that should seal off when the bank switches. However it was found that the medical air would blow by the shuttle valve back into the heater bar pressurizing it and cancelling the empty alarm thus giving a false pressure-reading. Since replacing the shuttle valve there have been no further incidents with loss of medical air.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611562-2003-00001 |
| MDR Report Key | 482878 |
| Report Source | 05,06 |
| Date Received | 2003-09-03 |
| Date of Report | 2003-09-03 |
| Date of Event | 2003-03-21 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2003-09-12 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 85 FULTON WAY |
| Manufacturer City | RICHMOND HILL, ONTARIO L4B 2N4 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4B 2N4 |
| Manufacturer Phone | 7640800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMICO CORP MICROPROCESSOR BASED DIGITAL MANIFOLD ALERT-2 |
| Generic Name | MEDICAL GAS MANIFOLD |
| Product Code | CAM |
| Date Received | 2003-09-03 |
| Model Number | M2LT-D-HH-U-AIR |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 462609 |
| Manufacturer | AMICO CORP. |
| Manufacturer Address | 85 FULTON WAY RICHMOND HILL, ONTARIO CA L4B 2H4 |
| Baseline Brand Name | AMICO CORP MICROPROCESSOR BASED DIGITAL MANIFOLD ALERT-2 |
| Baseline Generic Name | MEDICAL GAS MANIFOLD |
| Baseline Model No | M2LT-D-HH-U-AIR |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-09-03 |