|
|
| Catalog Number P-201 |
|
|
|
Event Description
|
Tubing between pt's nose and pendant reservoir kinked too easily.
Pt stated he was not getting enough oxygen.
Potential hypoxemia.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | OXIMETER PENDANT |
|---|
| Type of Device | OXIMETER PENDANT |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| CHAD THERAPEUTICS |
| 9445 desoto ave |
| chatsworth CA 91311 |
|
| Manufacturer (Section D) |
| CHAD THERAPEUTICS |
| 9445 desoto ave |
| chatsworth CA 91311 |
|
| Device Event Key | 30887 |
|---|
| MDR Report Key | 29808 |
|---|
| Event Key | 27955 |
|---|
| Report Number | 29808 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | CAN |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
Invalid Data
|
| Type of Report
| Initial |
|---|
| Report Date |
12/31/1995 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 12/31/1995 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Device Operator |
Invalid Data
|
| Device Catalogue Number | P-201 |
|---|
| Device LOT Number | 0194023 |
|---|
| Was Device Available For Evaluation? |
No Answer Provided
|
|---|
| Is The Reporter A Health Professional? |
No Answer Provided
|
|---|
| Was the Report Sent to FDA? |
No
|
|---|
| Event Location |
Hospital
|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
|
|
Database last updated on January 30, 2009
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