MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-31 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.
[98980768]
The customer was provided information for storage, repair, testing and replacement, and the customer opted to replace their vac pac device under warranty. 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
[98980769]
The customer initially contacted natus medical to report that their vac pac patient positioning support device would not hold suction. The customer also reported no visible damage and that the vac pac has been used regularly and often. 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) 2017 and has been destroyed at the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00081 |
| MDR Report Key | 7231727 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-03 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-31 |
| 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 | 2018-01-31 |
| Model Number | 51631 |
| Lot Number | N091316-05 |
| 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 | 2018-01-31 |