FDA Adverse Event
Malfunction
Summary report: N
FLUIDSMART FLUID MANAGEMENT SYSTEM
MDR report key: 15328261
·
Received August 31, 2022
Report
- Report Number
- 3007495879-2022-00006
- Event Type
- Malfunction
- Date Received
- August 31, 2022
- Date of Event
- October 15, 2021
- Report Date
- August 31, 2022
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- HIG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ALLEGED FAILURE: ON (B)(6) 2021 (B)(6) (TECH SERVICE) RECEIVED A CALL FROM (B)(6) (REP) EXPLAINING THAT SN (B)(4) WAS PRESENTING AN OVERPRESSURE SENSOR ERROR ALARM. PER 00824 OPERATION MANUAL REV K. AN OVER PRESSURE ALARM WILL PRESENT ITSELF WHEN THE PRESSURE SET POINT EXCEEDS 10% OR 12MM/HG. NO ONE WAS INJURED AS A RESULT. PROBABLE ROOT CAUSE/ROOT CAUSE: INCORRECT PROCEDURE SELECTION, OR INSUFFICIENT FLUID PRESSURE OR FLOW, COMPROMISING VISIBILITY.
Description of Event or Problem · 0
IT WAS REPORTED THAT DEVICE DISPLAYED AN OVERPRESSURE SENSOR ERROR ALARM. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1773887 | FLUIDSMART FLUID MANAGEMENT SYSTEM | INSUFFLATOR, HYSTEROSCOPIC | HIG | STRYKER ENDOSCOPY-SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |