FDA Adverse Event
Malfunction
Summary report: N
INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT
MDR report key: 1842105
·
Received August 24, 2010
Report
- Report Number
- 9611451-2010-00504
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- August 4, 2010
- Report Date
- August 4, 2010
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BZE
- PMA / PMN Number
- K034026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4): DATE OF MFR: UNK. QUANTITY: 1. THE COMPLAINT DEVICES HAVE NOT YET BEEN RECEIVED FOR EVAL. WE WILL PROVIDE A F/U REPORT UPON RECEIPT OF THE DEVICES AND COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 1
A HOSP IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT FOUR (4) RT236 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS "FAILED THE PT LEAK TEST ON THE SERVO-I" VENTILATOR. NO PT CONSEQUENCE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT | BZE | FISHER & PAYKEL HEALTHCARE, LTD. | RT236 | 091201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MAQUET SERVO-I VENTILATOR |