FDA Adverse Event
Death
Summary report: N
SPACELABS DIGITAL TELEMETRY TRANSMITTER
MDR report key: 3092879
·
Received May 3, 2013
Report
- Report Number
- 3023361-2013-00020
- Event Type
- Death
- Date Received
- May 3, 2013
- Date of Event
- February 5, 2013
- Report Date
- February 19, 2013
- Manufacturer
- SPACELABS MEDICAL INC.
- Product Code
- MHX
- PMA / PMN Number
- K983996
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
IT IS SPACELABS POLICY TO FILE A MEDWATCH REPORT WHENEVER A PT DEATH HAS OCCURED. SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A FOLLOW UP REPORT ONCE THE EVAL IS CONCLUDED.
Description of Event or Problem · 1
A PT WAS CONNECTED TO A TELEMETRY TRANSMITTER AND HAD ROLLED OVER ON HIS STOMACH AND STOPPED BREATHING. THE PT CODED AND DIED. NURSES ARE REPORTING THAT THEY DID NOT HEAR ANY ALARMS TO ALERT THEM TO THE PT NOT BREATHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195808 | SPACELABS DIGITAL TELEMETRY TRANSMITTER | TELEMETRY TRANSMITTER | MHX | SPACELABS MEDICAL INC. | 91343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death | 90478 (B)(6). | 91343 (B)(6).| 90478 (478-152258)| 91343 (1343-000925) |