MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2005-11-22 for DRAGERSORB UNK manufactured by Drager Medical Ag & Co. Kg.
[2204045]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9402634]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611500-2005-00037 |
| MDR Report Key | 2213798 |
| Report Source | 06,07 |
| Date Received | 2005-11-22 |
| Date of Report | 2005-11-21 |
| Date of Event | 2005-04-28 |
| Date Mfgr Received | 2005-10-24 |
| Date Added to Maude | 2011-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FRANK CLANZETT |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | LUBECK 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 4945188228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAGERSORB |
| Generic Name | ABSORBENT CARBON DIOXIDE |
| Product Code | BSF |
| Date Received | 2005-11-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAGER MEDICAL AG & CO. KG |
| Manufacturer Address | MOISLINGER ALLEE 53-55 LUBECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-11-22 |