MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-04-18 for AIRWAY PRESSURE MONITOR 332259 manufactured by Respironics, Inc..
[465470]
Information was received from the caregiver via a med watch report that a ventillator-dependent patient allegedly became disconnected from the ventillator. Neither the ventillator nor the subject device were reported to have alarmed. According to the caregiver,the patient was found 30 minutes later and had expired. At this time,it is unk if an autospy was performed. Both devices were reportedly being usedc in conjuction with a heat moisture exchanger (hme) for humidficaion. The ventillator's settings were reported as follows;mode: assist control, rate: 14, tidal volume: 330cc, high pressure alarm: 60cm h2o and low pressure alarm: 10cm h2o. The airway pressure monitor and circut were reported to have a high pressure setting of 60cm h2o and a low pressure setting of 10 cm h2o. The ventillator, airway pressure monitor and circut were elevated by the facility and it was determined that the hme had become clogged. The airway pressure monitor was reported to have registered 24 cm h2o of back pressure with the hme in line without being connected to a patient. Based on the low pressure alarm setting of 10 cm h2o and circut pressure of 24 cm h2o, the device would not recognize a disconnect as a low pressure condition with this low pressure alarm setting. The patient's peak pressure was reported to be 37 cm h2o. When the device and circut were tested with a newhme,the device was reported to have alarmed correctly. Medwatch 2518422-2006-00017 was previously filed on the ventillator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2006-00021 |
| MDR Report Key | 701003 |
| Report Source | 05,06 |
| Date Received | 2006-04-18 |
| Date of Report | 2006-03-20 |
| Date of Event | 2006-02-24 |
| Date Mfgr Received | 2006-03-20 |
| Date Added to Maude | 2006-04-20 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRWAY PRESSURE MONITOR |
| Generic Name | MONITOR, AIRWAY PRESSURE |
| Product Code | CAP |
| Date Received | 2006-04-18 |
| Model Number | 332259 |
| Catalog Number | 332259 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 690095 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 156688550 US |
| Baseline Brand Name | AIRWAY PRESSURE MONITOR |
| Baseline Generic Name | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| Baseline Model No | 332259 |
| Baseline Catalog No | 332259 |
| Baseline ID | NA |
| Baseline Device Family | MONITORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902276 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2006-04-18 |