MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-18 for PURITAN-BENNETT SERIES C-"GENESIS" NA manufactured by Nellcor Puritan Bennett, Inc..
[146040]
A respiratory care practitioner, while preparing to administer a breathing therapy, connected the described device into a standard 50 psig ohio diamond type medical air outlet. The flowmeter immediately burst apart into several pieces. The flow control knob propelled just past the therapist. There were two pts and three visitors in the room during the incident. However, no one was injured. Immediately after the incident, the medical air piping system was checked by this rptr and verified by the stationary engineer at 53 pounds per square inch gauge. Also, there were no active alarms. The flowmeter debris was collected and retained. The respiratory care staff, unit nursing staff, clinical engineers and risk manager were notified verbally and/or by internal written report. Also, all of these types of flowmeters are being collected for inspection and/or removal from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017933 |
| MDR Report Key | 258674 |
| Date Received | 2000-01-18 |
| Date of Report | 2000-01-05 |
| Date of Event | 2000-01-04 |
| Date Added to Maude | 2000-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PURITAN-BENNETT |
| Generic Name | PRESSURE COMPENSATED MEDICAL AIR FLOWMETER W/50PSI OUTLET |
| Product Code | CCN |
| Date Received | 2000-01-18 |
| Model Number | SERIES C-"GENESIS" |
| Catalog Number | NA |
| Lot Number | B(2) AJ |
| ID Number | MFG DATE 12/84 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 250503 |
| Manufacturer | NELLCOR PURITAN BENNETT, INC. |
| Manufacturer Address | 2200 FARADAY AVE. CARLSBAD CA 920087208 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-01-18 |