|
|
| Model Number PCA +2 |
| Event Date 01/20/1994 |
|
|
|
Event Description
|
Pca pump in pt's room making squealing noise.
Alarm malfunctioned and memory was lost.
|
| |
|
Search Alerts/Recalls
|
|
|
| Brand Name | PCA INFUSION PUMP |
|---|
| Type of Device | INFUSION PUMP |
|---|
| Baseline Device 510(K) Number | |
|---|
| Baseline Device PMA Number | |
|---|
| Manufacturer (Section F) |
| ABBOTT LABORATORIES |
| abbott park IL 60064 |
|
| Manufacturer (Section D) |
| ABBOTT LABORATORIES |
| abbott park IL 60064 |
|
| Device Event Key | 14917 |
|---|
| MDR Report Key | 14923 |
|---|
| Event Key | 11710 |
|---|
| Report Number | 14923 |
|---|
| Device Sequence Number | 1 |
|---|
| Product Code | MEA |
|---|
| Report Source |
User Facility
|
|---|
| Reporter Occupation |
Other
|
| Type of Report
| Initial |
|---|
| Report Date |
03/09/1994 |
| 1 Device Was Involved in the Event | |
| 1 Patient Was Involved in the Event | |
| Date FDA Received | 03/10/1994 |
|---|
| Is This An Adverse Event Report? |
No
|
|---|
| Is This A Product Problem Report? |
Yes
|
|---|
| Device Operator |
Health Professional
|
| Device MODEL Number | PCA +2 |
|---|
| Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
|---|
| Date Returned to Manufacturer | 03/03/1994 |
|---|
| Is The Reporter A Health Professional? |
Yes
|
|---|
| Was the Report Sent to FDA? |
Yes
|
|---|
| Date Report Sent to FDA | 03/09/1994 |
|---|
| Distributor Facility Aware Date | 01/20/1994 |
|---|
| Event Location |
Hospital
|
| Date Report TO Manufacturer | 03/09/1994 |
|---|
| Is the Device an Implant? |
No
|
|---|
| Is this an Explanted Device? |
|
|---|
|
|
Database last updated on January 30, 2009
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