FDA Adverse Event
Malfunction
Summary report: N
PEDIATRIC HOME HEALTH CARE CIRCUIT
MDR report key: 97353
·
Received June 5, 1997
Report
- Report Number
- 1718887-1997-00001
- Event Type
- Malfunction
- Date Received
- June 5, 1997
- Manufacturer
- MARQUEST MEDICAL PRODUCTS, INC.
- Product Code
- BZO
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
WHILE THE PATIENT WAS BEING MECHANICALLY VENTILATED THE LOW PRESSURE ALARM SOUNDED ALERTING THE USER OF A PROBLEM. THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR AND MANUALLY VENTILATED UNTIL A LIKE CIRCUIT COULD BE PRESSURE TESTED AND APPLIED. FOLLOWING THE PRESSURE TEST THE CIRCUIT WAS CONNECTED TO THE PATIENT AND MECHANICAL VENTILATION WAS RESUMED WITH NO FURTHER INCIDENCE. A VISUAL EXAMINATION OF THE CIRCUIT REVEALED A CRACK IN THE EXHALATION CAP CAUSING THE LOW VOLUME ALARM TO SOUND. THE PATIENT SUSTAINED NO INJURY AS A RESULT OF THE MALFUNCTION. THE INITIAL REPORT INVOLVED LOT 100315, HOWEVER THE EVALUATION SAMPLES RETURNED WERE 100478.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PEDIATRIC HOME HEALTH CARE CIRCUIT | RESPIRATORY BREATHING CIRCUIT | BZO | MARQUEST MEDICAL PRODUCTS, INC. | 156355 | 100315 CLAIMED LOT # |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |