MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-26 for VAC-PAC 51632 manufactured by Natus Medical Incorporated.
[109766345]
The tsr emailed the customer to request more information and the return of the suspect vac-pac device. On 5/08/2018, the tsr e-mailed the customer again, asking the customer if the vac-pac and questionnaire had been returned to natus medical. On 5/18/2018, the tsr sent another follow-up e-mail with no response. The customer was 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
[109766346]
The customer reported to a natus medical technical service representative (tsr) that size 32 vac-pac, lot #56 and purchased in november 2014, did not fully suction firm during surgery. There has been no report of death, serious injury or environmental/safety concerns. The vac-pac has been reported to have been used during a two hour debridement of a thoracic spine wound. The patient has been reported to have been in the lateral position, and the patient (b)(6). The customer stated the vac-pac was on continuous suction throughout the case, but that they noticed almost immediately after the procedure began that the vac-pac was not as firm as it should be. The customer also reported that the patient's abdominal panniculus was pushing up against the side of the vac-pac and that the scrub technician was able to keep the patient from moving or shifting. The customer could not confirm whether straps were in use during surgery but stated the vac-pac and patient had been taped to the operating room table. The tape had not been applied around the entire table, and because of this the tape did not hold very well. The procedure was completed without complication and there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00130 |
| MDR Report Key | 7547186 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-26 |
| Date of Report | 2018-04-27 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-05-26 |
| 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 | 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 | 2018-05-26 |
| Model Number | 51632 |
| Lot Number | 56 |
| 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 | 2018-05-26 |