MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-19 for D-VAPOR M35500 manufactured by Draegerwerk Ag & Co. Kgaa.
[95192383]
Patient Sequence No: 1, Text Type: N, H10
[95192384]
The patient was admitted for removal of an automatic implantable cardioverter-defibrillator (aicd) and cardiac leads in interventional radiology. The patient was intubated and sedated with fentanyl, propofol and rocuronium. Desflurane was being used as gas/inhaled anesthetic agent. Approximately 9 minutes after the patient was intubated she had an increase in bp and heart rate. The desflurane vaporizer gas data was not transmitting to the medical record, and was thought to be a software transmission issue. Clinical engineering was called. A clinical care tech re-seated the vaporizer in the anesthesia machine and it began to function appropriately, transmitting data. The patient was given additional midazolam and propofol in the event she was awake and paralyzed. Fortunately the physicians had used lidocaine to numb the area of the aicd generator area, however the patient did report a significant period of awareness once anesthesia was reversed at the end of the case. She required much post-procedure reassurance. Upon review by clinical engineering it was evident that the cross bar pins on the locking mechanism can easily shear off given the weight of the module, which occurred in this case. If only one of the pins locks the machine may still not be properly seated, but the user would not know using the naked eye since there is no indication the device is slightly askew. In addition, the locking handle has a spring loaded mechanism to keep the lock in place, however it easily breaks and may not ensure the device is properly seated in the anesthesia machine. Finally, there was no alarm indicated that the module was not seated properly, although the gas tracing did not register as anticipated. We think the pin locking mechanism could be better designed to make sure the device is properly seated and locked into the anesthesia machine. We are conducting an inventory of the devices and have found similar defects with other gas vaporizers. Manufacturer response for anesthestic gas vaporizer, desflurane drager d-vapor (per site reporter): no response as yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7128007 |
| MDR Report Key | 7128007 |
| Date Received | 2017-12-19 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-11-30 |
| Report Date | 2017-12-18 |
| Date Reported to FDA | 2017-12-18 |
| Date Reported to Mfgr | 2017-12-18 |
| Date Added to Maude | 2017-12-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | D-VAPOR |
| Generic Name | VAPORIZER, ANESTHESIA, NON-HEATED |
| Product Code | CAD |
| Date Received | 2017-12-19 |
| Model Number | M35500 |
| ID Number | M35500-06; ARWE-0230; BAXTER |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGERWERK AG & CO. KGAA |
| Manufacturer Address | BETH ZIS 6 TECH DR ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-19 |