MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-06 for VAC-PAC 51632 manufactured by Natus Medical Incorporated.
[99198998]
The suspect vac pac device was returned to natus and evaluated. A visual inspection confirmed a 30mm clean cut in the interior "u shape edge. The cut was patched with 10cm x 10cm cloth tape. Beads are coming out of the cut, and the cut is found on both the interior and exterior surfaces of the vac pac. The unit was returned with transparent dressing covering up a possible pinhole on back of the vac pac. A visual inspection also confirmed visible valve damage on surface of the valve opening where the valve plug goes in. Product examination also confirmed that the label does not adhere well on surface of the vac pac. 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
[99198999]
The customer contacted natus technical service to report that their vac pac lost suction during robotic right nephro-ureteroplasty surgery. The patient was in the lateral "jack-knife" position. Surgical staff noticed immediately that the patient began to shift on the operating room table. The customer reported that after the patient fell into the arms of a surgical assistant, they discovered a one inch cut/tear (approximately) near the seam of the vac pac. The customer reported that they applied tape to the affected area, and surgical staff then repositioned and secured the patient before continuing the surgery. Beads were found on the floor after the surgical drapes were removed from the patient. The customer reported a delay in surgery while the patient was being repositioned and secured, and there has been no report of patient or user harm. The vac pac has been reported to have been purchased in august 2016 and has been returned to natus for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00092 |
| MDR Report Key | 7246456 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-09 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2018-02-06 |
| 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 | ANA SZUCS |
| 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 | 2018-02-06 |
| Returned To Mfg | 2018-01-29 |
| Model Number | 51632 |
| Lot Number | N050416-04 |
| 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 | 2018-02-06 |