FDA Adverse Event
Malfunction
Summary report: N
ACCLAIM ENCORE 2.25
MDR report key: 1881699
·
Received October 11, 2010
Report
- Report Number
- 2921482-2010-00766
- Event Type
- Malfunction
- Date Received
- October 11, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K011096
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCLAIM ENCORE 2.25 | 80FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |