FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 2843575
·
Received October 24, 2012
Report
- Report Number
- 1314492-2012-00363
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Report Date
- September 24, 2012
- Manufacturer
- SIGMA HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SIGMA EVALUATED THE DEVICE IN QUESTION. THE SIGMA DEVICE EVALUATION FOUND THE #2, #3, #4, #5, #6, #7, #8, #9 AND (.) KEYS TO BE INOPERABLE. IT WAS OBSERVED THAT WHEN ANY REMAINING FUNCTIONAL KEYS ARE SELECTED, AN AUTOMATIC OUTPUT OF THE #3 KEY WILL OCCUR FOLLOWING THE SELECTED KEY'S FUNCTION (E.G. WHEN THE #1 KEY IS PRESSED 13 WILL BE DISPLAYED. WHEN IN ALPHABETIC MODE AND THE ABC KEY IS SELECTED, AG WILL BE DISPLAYED INTERFERING WITH THE MDL DRUG SEARCH). SIGMA'S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP KEYPAD WAS INOPERABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | SIGMA HEALTHCARE CORP. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |