MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-08 for PRESSURE ALARM 23001 manufactured by Respironics, Inc..
[503046]
Info was received alleging that an invasively ventilated pt became disconnected from the ventilator and expired. The ventilator (another mfr's) reportedly alarmed for low volume, but was not heard. The pressure alarm, which was located outside the pt room allegedly did not alarm at the time of the event. The circuit (another mfr's) in use included a heat moisture exchanger and an adaptor for the pressure alarm. The adaptor for the pressure alarm was located between the "y" of the pt circuit and the heat moisture exchanger. The disconnection reportedly occurred at the tracheostomy tube, leaving the heat moisture exchanger and pressure alarm adaptor attached to the circuit. The low pressure threshold was reportedly set at 10 cmh2o on the pressure alarm, but according to independent testing, the disconnect did not cause the device to alarm because the heat moisture exchanger held 30 cm h20 of back pressure in the circuit. Independent testing by an outside consultant confirmed the pressure alarm was functioning to specification. There is no allegation of device malfunction, and it appears that the back pressure in the circuit caused by the use of a heat moisture exchanger may have prevented the low pressure alarm from sounding because of the threshold setting of 10 cmh20. No autopsy was performed on the pt to determine the cause of death.
Patient Sequence No: 1, Text Type: D, B5
[7837590]
The device was not returned to the mfr for evaluation. The device was evaluated at the facility by an indepenent outside consultant and was found to be performing to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2006-00055 |
| MDR Report Key | 758144 |
| Report Source | 05,06 |
| Date Received | 2006-09-08 |
| Date of Report | 2006-08-10 |
| Date of Event | 2006-08-10 |
| Date Mfgr Received | 2006-08-10 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-09-11 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | LOUANNE KINNEY |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer Phone | 7243874292 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRESSURE ALARM |
| Generic Name | AIRWAY PRESSURE ALARM |
| Product Code | CAP |
| Date Received | 2006-09-08 |
| Model Number | 23001 |
| Catalog Number | 23001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 746043 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-09-08 |