FDA Adverse Event
Malfunction
Summary report: N
HUDSON WATER AQUAPAK HUMIDIFIERS, 340 ML INTL
MDR report key: 2160199
·
Received June 2, 2011
Report
- Report Number
- 1417411-2011-00051
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 19, 2011
- Report Date
- May 20, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION. THE INITIAL LOT NUMBER WAS IDENTIFIED AS LOT #085117. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(4) 2011, STATING THAT THE INITIAL REPORTED LOT # CAN NOT BE CONFIRMED, BECAUSE THE PRODUCT WAS NOT DECONTAMINATED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: "AQUAPAK HAS BEEN INSTALLED SINCE (B)(6) 2011 WHEN THE EVENT OCCURRED. THERE WAS A DESATURATION OF THE PATIENT W/O CLINICAL SIGNS ASSOCIATED. THEN, THE NURSE HAS CONTROLLED THE AQUAPAK CONNECTION AND NOTICED THAT THE ADAPTOR WAS CRACKED ALLEGEDLY LEADING TO THE LEAK. ANOTHER AQUAPAK WAS SUCCESSFULLY USED." PATIENT CURRENT CONDITION IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON WATER AQUAPAK HUMIDIFIERS, 340 ML INTL | HUMIDIFIERS | CAF | TELEFLEX MEDICAL | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |