MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-02 for ALLURA XPER FD20 OR TABLE 722035 manufactured by Philips Healthcare.
[39440043]
(b)(4). When the investigation is completed philips will inform the fda.
Patient Sequence No: 1, Text Type: N, H10
[39440044]
Philips received a complaint from the customer in which they stated that a patient died after surgery. After the procedure was finished the patient needed to be tilted head down to recover from anesthesia the table could not be moved because e-stop was accidently activated by the staff and no one noticed. At this moment it's still unclear if this caused the death of the patient. As this is a hybrid system the table can used as standalone device for surgery, the allura system was not used for this procedure.
Patient Sequence No: 1, Text Type: D, B5
[45316286]
A philips service engineer checked the log files and found that a staff member activated the emergency stop on the allura system which locked the table, making it impossible to move the table into the trendelenburg position. Since there was no need for the allura system except for the flex vision monitor which was displaying the patents? Vitals, there was only operating room staff in the room and no cath lab or radiology staff. As confirmed by the customer, the or staff only had minimal participation in the handover training and was unable to reset the stop signal. Usually in surgery only cases the allura system is kept off and the maquet table functions independently from it. When the allura system is kept off the emergency stop buttons on the mcs and tso are nonfunctional. The staff supervisors have been informed with a demonstration how to use the maquet table after the incident. The hospital has taken the action to have at least one trained member of personnel available in the room when used during medical procedures. According the hospital staff the system did not contribute to the death of the patient. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768277-2016-00022 |
| MDR Report Key | 5473350 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-02 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-02-05 |
| Date Added to Maude | 2016-03-02 |
| 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. DUSTY LEPPERT |
| Manufacturer Street | VEENPLUIS 4-6 P.O. BOX 10.000 |
| Manufacturer City | BEST 5680DA |
| Manufacturer Country | NL |
| Manufacturer Postal | 5680 DA |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLURA XPER FD20 OR TABLE |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER |
| Product Code | OWB |
| Date Received | 2016-03-02 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Brand Name | ALLURA XPER FD20 OR TABLE |
| Generic Name | ANGIOGRAPHIC X-RAY SYSTEM, SOLID X-RAY IMAGER |
| Product Code | OBW |
| Date Received | 2016-03-02 |
| Model Number | 722035 |
| Catalog Number | 722035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | VEENPLUIS 4-6 P.O. BOX 10.000 BEST 5680DA NL 5680 DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-03-02 |