FDA Adverse Event
Injury
Summary report: N
PULMONETIC SYSTEMS, INC.
MDR report key: 540241
·
Received August 18, 2004
Report
- Report Number
- 2031702-2004-00171
- Event Type
- Injury
- Date Received
- August 18, 2004
- Date of Event
- July 25, 2004
- Report Date
- August 18, 2004
- Manufacturer
- PULMONETIC SYSTEMS, INC.
- Product Code
- CAI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
PT USING A DISPOSABLE PEDIATRIC CIRCUIT WITH PEEP AND WATER TRAP. FAMILY MEMBER HEARD A "HISSING" FROM VENT, BUT IT SEEMED OK. FAMILY MEMBER LATER NOTICED PT APPEARED TO BE HAVING TROUBLE BREATHING. FAMILY MEMBER LOOKED AT THE PEEP ON THE SCREEN-AND IT WAS "0". PT'S SPO2 DROPPED. NO ALARMS FOR LOW PEEP. FAMILY MEMBER IMMEDIATELY SWITCHED PT TO THEIR BACK UP VENT, WHICH WAS OK. PT RECOVERED QUICKLY. FAMILY MEMBER STATED DIAPHRAGM LOOKED "SHRIVELD." THEY CHANGED CIRCUIT ONE TIME PER WEEK. PT HAS LARGE LEAK, NO LOW MINUTE VOLUME ALARM SET - WAS A CONTINUOUS NUISANCE. FAMILY MEMBER ALLEGING PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONETIC SYSTEMS, INC. | BREATHING CIRCUIT WITH PEEP AND WATER TRAP, DISPOSIBLE | CAI | PULMONETIC SYSTEMS, INC. | 11505 | 025569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |