FDA Adverse Event
Malfunction
Summary report: N
LIFECARE PCA 3 V4.1
MDR report key: 1942132
·
Received November 15, 2010
Report
- Report Number
- 2921482-2010-00889
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 6, 2010
- Report Date
- October 18, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- MEA
- PMA / PMN Number
- K043256
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT DURING INCOMING INSPECTION AT THE USER FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFECARE PCA 3 V4.1 | 80MEA | MEA | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |