FDA Adverse Event
Malfunction
Summary report: N
PRONTO 7
MDR report key: 4250099
·
Received August 22, 2013
Report
- Report Number
- 2031172-2014-00143
- Event Type
- Malfunction
- Date Received
- August 22, 2013
- Date of Event
- July 10, 2014
- Report Date
- July 25, 2014
- Manufacturer
- MASIMO CORPORATION
- Product Code
- DQA
- PMA / PMN Number
- K111403
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THEY ARE UNHAPPY WITH SPHB TEST RESULTS ON THE PRONTO-7. IT HAS BECOME EXTREMELY SENSITIVE AND IT IS NOT POSSIBLE TO OBTAIN HEMOGLOBIN RESULTS ON PATIENTS. ADD'L INFO WAS MADE AVAILABLE ON 07/25/2014: IN GENERAL THE PRONTO 7 IS SENSITIVE TO MOTION. THE CUSTOMER STATED THAT IT WAS GIVING INACCURATE READINGS. NO PT INCIDENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409217 | PRONTO 7 | DQA | MASIMO CORPORATION | 9221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |