MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-06 for VASOPRESS DIGITAL MINI PUMP VP500DM manufactured by Zimmer Surgical, Inc..
[178350758]
(b)(4). Device product code: jow. 510(k) number: k101915 & k061814. Product review of the vp500dm vasopress pump performed by zimmer biomet surgical on october 31, 2019 revealed that the power cord was damaged and the wires were exposed. Repair of the vp500dm vasopress pump performed by zimmer biomet surgical on october 31, 2019 included replacement of the power cord. Vp500dm vasopress pump, serial number (b)(4), was then tested and functioned properly. It was repaired, inspected and tested. The reported event " the device had a hole in the power cord " was confirmed since during product review the power cord was damaged and wire was exposed. A definitive root cause of the damaged power cord could not be determined with the provided information since the cause for power cord damage is unknown. The power cord was replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d). This is a well-known failure mode, with no allegations of harm or injury. This complaint will be tracked and trended for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[178350759]
It was reported that the unit had a hole in the power cord. There was no patient impact and not an out of box failure. The event occurred during testing. The investigation identified the presence of exposed wires. No adverse events have been reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00021 |
| MDR Report Key | 9555052 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-10-19 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-06 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASOPRESS DIGITAL MINI PUMP |
| Generic Name | SLEEVE, LIMB, COMPRESSIBLE |
| Product Code | JOW |
| Date Received | 2020-01-06 |
| Returned To Mfg | 2019-10-23 |
| Catalog Number | VP500DM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |