FDA Adverse Event
Other
Summary report: N
DATEX-OHMEDA ESTPR MODULE
MDR report key: 211300
·
Received February 17, 1999
Report
- Report Number
- 9610105-1999-00001
- Event Type
- Other
- Date Received
- February 17, 1999
- Report Date
- February 17, 1999
- Manufacturer
- DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP.
- Product Code
- BZQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TELETRONICS META III MINUTE VENTILATION RATE ADAPTIVE CARDIAC PACEMAKER ERRONEOUSLY INTERPRETED AS/3 PATIENT MONITOR'S RESPIRATION RATE MEASUREMENT (BIOELECTRIC IMPEDANCE MEASUREMENT) RESULTING RISE IN THE PACING RATE OF THE PACEMAKER AND SUBSEQUENTLY DECREASE IN BLOOD PRESSURE OF THE PATIENT. THE PATIENT RECOVERED SPONTANEOUSLY AFTER DISCONNECTION FROM THE MONITOR. NO NEGATIVE OUTCOME ON THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DATEX-OHMEDA ESTPR MODULE | MULTIPARAMETER PATIENT MONITOR | BZQ | DATEX-OHMEDA DIVISION, INSTRUMENTARIUM CORP. | M-ESTPR | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | UNK).| TELETRONICS META III CARDIAC PACEMAKER (UNK TO |