FDA Adverse Event
Malfunction
Summary report: N
LIFECARE PCA 3 V5.06
MDR report key: 4110529
·
Received September 16, 2014
Report
- Report Number
- 9615050-2014-05243
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 9, 2014
- Report Date
- August 28, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- MEA
- PMA / PMN Number
- K042800
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AND ALARM CONDITION. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. NO INFORMATION WAS PROVIDED; THEREFORE, SPECIFIC PT INFORMATION, PUMP PROGRAMMING, OR EVENT DETAILS WERE NOT AVAILABLE. DURING TESTING AT THE USER FACILITY, THE CUSTOMER CONTACT REPORTED THE SOUND LEVEL IS WEAK. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572704 | LIFECARE PCA 3 V5.06 | 80MEA | MEA | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |