D
Patient 1
(B)(4).
MAUDE MDR 2213798
- MDR report key
- 2213798
- Report number
- 9611500-2005-00037
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-04-28
- Date received
- 2005-11-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Manufacturer Contact#
- Contact
- MR FRANK CLANZETT
- Address
- MOISLINGER ALLEE 53-55 LUBECK 23542 GM
- Phone
- 494-494-4945
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DRAGERSORB | ABSORBENT CARBON DIOXIDE | DRAGER MEDICAL AG & CO. KG | BSF | UNK | UNK | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-11-22 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE INITIAL REPORTER WAS CONTACTED AND GAVE FOLLOWING ADDITIONAL INFO. THE REPORTER STATED, THAT THERE WAS NO PT INJURY. THE QUESTION, WHY IT TOOK 5 MONTHS BETWEEN DATE OF EVENT AND THE USER FACILITY REPORT WAS ANSWERED BY HOSPITAL INTERNAL INVESTIGATION; THE RESULTS OF THIS INVESTIGATION WAS NOT MADE AVAILABLE TO THE IMPORTER/MFR ON REQUEST. ALSO THE AFFECTED CO2 ABSORBENT WAS NOT BEEN MADE AVAILABLE FOR INVESTIGATION AT MFR SITE, AS REQUESTED. THE INITIAL REPORTER WAS NOT ABLE TO PROVIDE INFO ABOUT THE ANESTHESIA MACHINE ON WHICH THE OCCURRENCE WAS REPORTED. DUE TO THE LACK OF FURTHER FEASABLE INFO AND TO THE FACT THAT THE AFFECTED PRODUCT HAS NOT BEEN MADE AVAILABLE FOR INVESTIGATION THE COMPLAINT HAS BEEN CLOSED. THE REPORTED EVENT COULD NOT BE RETRACED.