MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-12-22 for OXYGEN FLOW CONTROLLER 6-900011-00 manufactured by Puritan Bennett, Cryogenic Equipment Division.
[20923429]
The following info was reported from the ambulance company: (1) a pt was being transported and was being supported by a portable pneumatic ventilator when the alarm activated. (2) the pt was taken off the ventilator and was vented using a "bvm" connected to the pt's endotracheal tube with the oxygen flow controller set at 25 lpm. (3) while venting the pt with the bvm, the pt's spo2% saturation continued to decrease despite the flow controller indicating 25 lpm. (4) the pt was switched to another oxygen source. (5) the pt was listed in stable condition after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825511-1999-00020 |
| MDR Report Key | 256985 |
| Report Source | 05 |
| Date Received | 1999-12-22 |
| Date of Report | 1999-12-22 |
| Date of Event | 1999-09-08 |
| Date Mfgr Received | 1999-11-22 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 2000-01-03 |
| 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 |
| Manufacturer Contact | ANGELA DICKSON |
| Manufacturer Street | 5647 DIVIDEND DRIVE |
| Manufacturer City | INDIANAPOLIS IN 46241 |
| Manufacturer Country | US |
| Manufacturer Postal | 46241 |
| Manufacturer Phone | 3712488060 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN FLOW CONTROLLER |
| Generic Name | FLOW CONTROLLER |
| Product Code | CCN |
| Date Received | 1999-12-22 |
| Returned To Mfg | 1999-11-22 |
| Model Number | NA |
| Catalog Number | 6-900011-00 |
| Lot Number | 960216 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 248860 |
| Manufacturer | PURITAN BENNETT, CRYOGENIC EQUIPMENT DIVISION |
| Manufacturer Address | 5647 DIVIDEND DR. INDIANAPOLIS IN 46241 US |
| Baseline Brand Name | OXYGEN FLOW CONTROLLER |
| Baseline Generic Name | FLOW CONTROLLER |
| Baseline Model No | NA |
| Baseline Catalog No | 6-900011-00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-12-22 |