MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-13 for VAC-PAC 51632 manufactured by Natus Medical Incorporated.
[105659202]
The unit was returned to natus and evaluated. The customer reported a tear, but no visible damage was found. Adhesive build up was noticed on the vac-pac. The vac-pac remained suctioned, firm and flat for 24 hours, and the failure could not be replicated. 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
[105659203]
The customer reported that the vac-pac lost suction during surgery. The customer stated this vac-pac may have been used only a few times since it is new (under warranty), but they are not certain. The customer reported no patient harm or environmental concerns, but there was a delay in surgery while they connected the vac-pac to suction so they could complete the surgery. The customer reported that they noticed a tear while packing the unit for return shipment. The vac-pac has been returned to natus medical for qa evaluation on 4/10/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00115 |
| MDR Report Key | 7430023 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Date Added to Maude | 2018-04-13 |
| 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 | 2018-04-13 |
| Returned To Mfg | 2018-04-10 |
| Model Number | 51632 |
| Lot Number | N081417-05 |
| 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 | 2018-04-13 |