MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-01-19 for DRAEGER C2000 N/A manufactured by Draeger Medical Systems, Inc..
[97742515]
The preliminary investigation indicates the incubator functioned as intended based on the testing performed at the facility by the quality manager and draeger field service representatives and did not contribute to patient death. The police and national csi confirmed there was no functional problem with the c2000 incubator. Draeger will continue to monitor the situation as the government level survey is still in progress and will take approximately one month to complete.
Patient Sequence No: 1, Text Type: N, H10
[97742516]
Four newborns died within a two hour span while being treated at the intensive care unit for newborns at the hospital and suffered sudden cardiac arrest at different times, starting from around 5:40 pm on saturday night. The staff tried to revive the newborns through cpr but could not. The hospital is working with the public health centers and authorities to find the cause of their deaths. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[101529292]
The investigation indicates the incubators functioned as intended based on the testing performed at the facility by the quality manager and draeger field service representatives and did not contribute to patients deaths. The police and national csi confirmed there was no functional problem with the c2000 incubator. Clarification was received indicating the government investigation determined the infectious management of the hospital was the root cause of the patients deaths and the incubators involved did not contribute to the patients outcome and the government investigation has been closed. Devices preformed as intended and did not contribute to the patient deaths.
Patient Sequence No: 1, Text Type: N, H10
[101529293]
Four newborns died within a two hour span while being treated at the intensive care unit for newborns at the hospital and suffered sudden cardiac arrest at different times, starting from around 5:40 pm on saturday night. The staff tried to revive the newborns through cpr but could not. The hospital is working with the public health centers and authorities to find the cause of their deaths. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2018-00001 |
| MDR Report Key | 7205648 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-01-19 |
| Date of Report | 2018-02-27 |
| Date of Event | 2017-12-16 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2010-03-26 |
| Date Added to Maude | 2018-01-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DHAVAL TRIVEDI |
| Manufacturer Street | 3135 QUARRY ROAD |
| Manufacturer City | TELFORD PA 18969 |
| Manufacturer Country | US |
| Manufacturer Postal | 18969 |
| Manufacturer Phone | 9783798077 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRAEGER |
| Generic Name | INCUBATOR, INFANT, STATIONARY |
| Product Code | FMZ |
| Date Received | 2018-01-19 |
| Model Number | C2000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 3135 QUARRY ROAD TELFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-01-19 |