MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-08 for VAC-PAC 51631 manufactured by Natus Medical Incorporated.
[107691657]
Natus qa evaluated the returned vac-pac, which had been repaired with one half of a patch next to the valve stem. The returned vac-pac was suctioned and remained firm for 72 hours. When the patch was removed, the vac-pac softened. A 0. 5cm tear was observed 2. 0cm from the valve stem, and qa suspected that the tear may have been caused by a towel clamp. The complainant opted to replace their vac-pac 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.
Patient Sequence No: 1, Text Type: N, H10
[107691658]
Natus received a report that a vac-pac had softened during a lateral shoulder procedure which lasted approximately three hours. The complainant initially noticed that the vac-pac had softened when the patient was placed on it prior to surgery prep. Suction was re-applied, the valve cap was closed, and the vac-pac was subsequently used during surgery. After the surgery, it was noted that the vac-pac had become flaccid. Upon inspection of the vac-pac, a small tear was noticed near the valve and beads originating from the vac-pac were seen on the patient bed. The complainant stated that vac-pacs are stored firm and flat, and they had not noticed a tear prior to surgery. The vac-pac was purchased in (b)(6) 2017. The complainant noted a slipping of an arthrex s3 traction tower during surgery which could have possibly been related to a lack of lateral support provided by the vac-pac. The complainant stated that the patient did not lose position during surgery as the vac-pac was taped to the operating room table and securing posts were attached. There was no report of death, serious injury, delay in treatment, or environmental/safety concerns. The complainant stated that there was no harm caused to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00121 |
| MDR Report Key | 7496931 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-08 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-08 |
| 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 | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| 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 | 2018-05-08 |
| Returned To Mfg | 2018-04-26 |
| Model Number | 51631 |
| Lot Number | N020617-06 |
| Operator | NURSE |
| 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 | 2018-05-08 |