MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-12 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.
[105521831]
The suspect vac pac device was returned to natus and evaluated. A visual inspection confirmed that the side baffle on front of vac-pac has 0. 7 cm hole that is three inches from the seam. The likely cause of the loss of suction is customer-caused damage. The customer was provided information for storage, repair, testing and replacement. 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 that are used several times a week.
Patient Sequence No: 1, Text Type: N, H10
[105521832]
The customer reported that this vac-pac lost suction during surgery. The vac-pac softened during surgery, and the staff connected it to continuous suction and completed the surgical procedure. There has been no report of death, serious injury or delay in patient treatment. The vac-pac has been returned to natus medical for qa evaluation on 4/10/2018. The vac-pac was purchased in (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00113 |
| MDR Report Key | 7427114 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-15 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-12 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685133 |
| 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 | 2018-04-12 |
| Returned To Mfg | 2018-04-10 |
| Model Number | 51631 |
| Lot Number | N020617-05 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-04-12 |