MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-08-17 for VAC-PAC 51630 manufactured by Natus Medical Incorporated.
[117857946]
The customer was provided information for storage, repair, testing and replacement. Natus technical service advised the user that the vac-pac ifu notes to choose a vac-pac that supports the patient and to use additional supports as needed. Users are instructed to check the vac-pac device before and after each use and not to use the device if there is known damage or a leak. Users are also instructed to replace units older than two years.
Patient Sequence No: 1, Text Type: N, H10
[117857947]
It was reported to natus that a vac-pac lost suction during a surgical procedure while connected to continuous suction. Upon loss of suction, the patient began sliding off of the operating room table. The anesthesiologist was able to stop the patient's slide. There was no harm caused to the patient. It was not reported whether there was any visible damage to the vac-pac. The vac-pac was reported to have been purchased over two years prior to the date of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00145 |
| MDR Report Key | 7794970 |
| Report Source | USER FACILITY |
| Date Received | 2018-08-17 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Date Added to Maude | 2018-08-17 |
| 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 | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAC-PAC |
| Generic Name | VAC-PAC |
| Product Code | CCX |
| Date Received | 2018-08-17 |
| Model Number | 51630 |
| Lot Number | 301724-509E |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-17 |