MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-07-01 for PULMONARY FUNCTION LABORATORY 2200 765985 manufactured by Sensormedics Corp..
[18554156]
The model 2200 apparently developed a leak which caused diffusion gas to back up into and contaminate the hospital's oxygen lines. This caused the oxygen alarms in a nearby ventilator room to sound. The ventilator room was evacuated to investigate the problem. According to the reporter, there were no injuries to anyone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050001-1999-00069 |
| MDR Report Key | 230834 |
| Report Source | 05,06,07 |
| Date Received | 1999-07-01 |
| Date of Report | 1999-07-01 |
| Date of Event | 1999-06-15 |
| Date Mfgr Received | 1999-06-15 |
| Device Manufacturer Date | 1991-07-01 |
| Date Added to Maude | 1999-07-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULMONARY FUNCTION LABORATORY |
| Generic Name | PULMONARY TESTING SYSTEM |
| Product Code | BZC |
| Date Received | 1999-07-01 |
| Model Number | 2200 |
| Catalog Number | 765985 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 223789 |
| Manufacturer | SENSORMEDICS CORP. |
| Manufacturer Address | 22705 SAVI RANCH PKWY. YORBA LINDA CA 928874645 US |
| Baseline Brand Name | PULMONARY FUNCTION LAB |
| Baseline Generic Name | PULMONARY TESTING SYSTEM |
| Baseline Model No | 2200 |
| Baseline Catalog No | 765985 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K923988 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-07-01 |