MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for TEMPERATURE/FLOW PROBE 900MR869 manufactured by Fisher & Paykel Healthcare Ltd.
[184799408]
(b)(4). We are in the process of obtaining further information from the customer to determine if the 900mr869 temperature/flow probe caused or contributed to the reported event. We will provide a follow up report upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[184799409]
A healthcare facility in ontario reported via a fisher & paykel healthcare (f&p) representative that a 900mr869 temperature/flow probe dislodged from a breathing circuit during use. It was further reported that the interruption in ventilation contributed to the patient, who was critically ill and unstable, to deteriorate. The patient went into organ failure and deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611451-2020-00309 |
| MDR Report Key | 9876221 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 | 3 |
| Manufacturer Contact | MS FARANAK GOMAROONI |
| Manufacturer Street | 173 TECHNOLOGY DRIVE SUITE 100 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4534000 |
| Manufacturer G1 | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Street | 15 MAURICE PAYKEL PLACE EAST TAMAKI |
| Manufacturer City | AUCKLAND, 2013 |
| Manufacturer Country | NZ |
| Manufacturer Postal Code | 2013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPERATURE/FLOW PROBE |
| Generic Name | BTT |
| Product Code | BTT |
| Date Received | 2020-03-24 |
| Model Number | 900MR869 |
| Catalog Number | 900MR869 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER & PAYKEL HEALTHCARE LTD |
| Manufacturer Address | 15 MAURICE PAYKEL PLACE EAST TAMAKI AUCKLAND, 2013 NZ 2013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-24 |