FDA Adverse Event
Death
Summary report: N
C-MAC POCKET MONITOR
MDR report key: 7077535
·
Received December 1, 2017
Report
- Report Number
- 9610617-2017-00097
- Event Type
- Death
- Date Received
- December 1, 2017
- Date of Event
- November 10, 2017
- Report Date
- November 13, 2017
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- CCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
THE CMAC POCKET MONITOR WAS NOT RETURNED TO KARL STORZ FOR EVALUATION.
Description of Event or Problem · 1
ALLEGEDLY, DURING AN INTUBATION OF A INFANT, THE CMAC POCKET MONITOR STOPPED WORKING WITHIN 2-3 MINUTES DESPITE THE CHARGER INDICATING A FULL CHARGE. ALTHOUGH THE INFANT DID NOT SURVIVE, THE HOSPITAL RESPIRATORY THERAPIST STATED THAT ITS DEMISE WAS NOT RELATED TO THE CMAC POCKET MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853305 | C-MAC POCKET MONITOR | C-MAC POCKET MONITOR | CCW | KARL STORZ GMBH & CO. KG | 8401XDK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 WK | Death |