MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2006-04-27 for RIGHT ANGLE AIRWAY PRONE 9600MR561 manufactured by Fisher & Paykel Healthcare, Ltd..
[456191]
Fisher and paykel healthcare (fphc) received a report from cardinal health regarding an alleged fire. The patient had been on a fphc rt110 breathing circuit for about 24 hours. The humidifier was the fphc mr 370 and associated accessories, with mr290 humidification chamber. The patient, ventilator, humidifier and circuit were transported to the cath lab for a procedure. A respiratory therapist then went about his/her duties. During the procedure ( a period of about 1 hour) it was reported that the nursing staff silenced the mr730 alarms at least twice. The cause of the alarms is unknown. The respiratory therapist was called to respond to the cath lab stat and upon entering the area, immediately noted that the circuit was apparently melted and there allegedly were flames and sparks coming from the respiratory limb and a portion of the patient drape. The respiratory therapist immeidately assisted the patient suctioning and provided appropriate ventilation and oxygenation. There is no reported injury or concern for the patient at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2006-00005 |
| MDR Report Key | 704481 |
| Report Source | 06,07,08 |
| Date Received | 2006-04-27 |
| Date of Report | 2006-03-28 |
| Date of Event | 2006-03-27 |
| Date Mfgr Received | 2006-03-31 |
| Date Added to Maude | 2006-04-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RENETA MONEY |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI, PO BOX 14348 |
| Manufacturer City | PANMURE, AUCKLAND |
| Manufacturer Country | NZ |
| Manufacturer Phone | 5740100 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RIGHT ANGLE AIRWAY PRONE |
| Generic Name | TEMPERATURE PROBE |
| Product Code | HCS |
| Date Received | 2006-04-27 |
| Model Number | 9600MR561 |
| Catalog Number | 9600MR561 |
| Lot Number | 031015 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 693566 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE, LTD. |
| Manufacturer Address | * AUCKLAND NZ |
| Baseline Brand Name | RIGHT ANGLE AIRWAY PRONE |
| Baseline Generic Name | TEMPERATURE PROBE |
| Baseline Model No | 9600MR561 |
| Baseline Catalog No | 9600MR561 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-27 |