MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-04-23 for VAC-PAC manufactured by Natus Medical Incorporated.
[106259808]
No device malfunction has been reported in this complaint, but a potential injury involving the vac-pac device has been reported to natus. The customer has been contacted on 4/5/2018, 4/16/2018 and 4/19/2018. No additional information surrounding the event has been provided. Customers are 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
[106259809]
The customer reported to the natus technical service rep (tsr) that a patient appeared to have difficulty with one of his legs after a surgical procedure involving a vac-pac. The customer did not know the exact diagnosis but it appeared to be musculoskeletal or neurological in nature. The customer stated she was notified by an operating room educator that the incident happened approximately "a week or two ago. " no information regarding size or lot number was reported. She stated the male patient was undergoing a shoulder surgery and was placed in the lateral position. The customer also confirmed the vac-pac stayed firm throughout the surgery. The male patient has been reported to be (b)(6). , and the duration of the surgery is unknown. There has been no report of death, serious injury or delay in treatment. No environmental concerns have also been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00119 |
| MDR Report Key | 7452939 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-23 |
| Date of Report | 2018-03-25 |
| Date Mfgr Received | 2018-03-25 |
| Date Added to Maude | 2018-04-23 |
| 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 | 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAC-PAC |
| Generic Name | VAC-PAC |
| Product Code | CCX |
| Date Received | 2018-04-23 |
| 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 | 2018-04-23 |