MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-09 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.
[99885882]
The customer was provided information for storage, repair, testing and replacement, and the customer opted to replace their vac-pac. 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
[99885883]
The customer contacted natus medical to report that their vac-pac patient positioning support device had a slow leak at the valve. There was no report of death, injury or delay in treatment, and no patient involvement was reported. The vac-pac device has been reported to have been purchased in (b)(6) 2016 and has been destroyed at the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00100 |
| MDR Report Key | 7261350 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-09 |
| Date of Report | 2018-01-11 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2018-02-09 |
| 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 | KYLE HORTON |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2068343921 |
| 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 | 2018-02-09 |
| Model Number | 51631 |
| Lot Number | N050416-06 |
| 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 | 2018-02-09 |