FDA Adverse Event
Malfunction
Summary report: N
ACCLAIM ENCORE 2.25
MDR report key: 3915196
·
Received May 16, 2014
Report
- Report Number
- 9615050-2014-03474
- Event Type
- Malfunction
- Date Received
- May 16, 2014
- Date of Event
- April 22, 2014
- Report Date
- April 22, 2014
- Manufacturer
- HOSPIRA COSTA RICA LTD.
- Product Code
- FRN
- PMA / PMN Number
- K011096
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. 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 THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE POWERED OFF BY ITSELF WHILE ON BATTERY POWER WITHOUT SOUNDING AN AUDIBLE ALARM TONE. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 293968 | ACCLAIM ENCORE 2.25 | 80FRN | FRN | HOSPIRA COSTA RICA LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |