MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-02-23 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.
[101007406]
The customer representative contacted natus technical service while the vac-pac was still under the patient, so the lot number and age of device were unavailable during the time of the initial call. Natus technical service contacted the customer on 1/26/2018, 02/01/2018, 02/02/2018 and 02/06/2018 for more information and for return of the faulty unit. The customer reported on 02/06/2018 that the vac-pac had been destroyed on (b)(6) 2018 after the surgery and that the vac-pac had no visible damage. The customer was unable to provide lot number or device age. Technical service continued to contact the customer on 02/12/2018 and 02/15/2018. These attempts to contact the customer were unsuccessful. Natus records show that the customer ordered two vac-pac units on 2/5/2018. 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
[101007407]
The customer contacted natus technical service to report a vac-pac that lost suction during surgery. The customer reported that the patient was in a lateral position while undergoing a foot surgery when the vac-pac lost suction. Safety straps were reported to be used on the patient as well. The customer reported that they repositioned the patient, connected the vac-pac to continuous suction and continued the surgery. The customer did report a delay in surgery, but no patient or user harm has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00104 |
| MDR Report Key | 7293291 |
| Report Source | USER FACILITY |
| Date Received | 2018-02-23 |
| Date of Report | 2018-01-24 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-24 |
| Date Added to Maude | 2018-02-23 |
| 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 | 2018-02-23 |
| Model Number | 51631 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-02-23 |