MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-13 for VASOPRESS DIGITAL MINI PUMP N/A VP500DM manufactured by Zimmer Surgical, Inc..
[179414079]
(b)(4). Device product code: jow. (b)(4). Could not confirm the alarm issue. Replaced the damaged power cord and face label. The reported event, "cp/op" is not confirmed and "power cord damage and open wires" are confirmed. The reported event "cp/op" was not confirmed since the device functioned as intended during product review; hence, a root cause cannot be determined. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Damage to the power cord can occur by the cord/plug mold being run over by wheeled equipment or by the cord being pulled from the wall outlet inadvertently. In some cases, damage to the wire coverings and insulation may expose the wires of the cord when excessive force is applied in a clinical setting. Under normal conditions the power cord and plug mold are not likely to become damaged. For vp500dm: the average age of the power cord during replacement is 2. 5 years. The failure rate for the power cord is (b)(4)%. 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
[179414080]
It was reported that there were exposed/frayed wires. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00055 |
| MDR Report Key | 9582810 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Returned To Mfg | 2019-11-07 |
| Model Number | N/A |
| Catalog Number | VP500DM |
| Lot Number | UNK |
| 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 | 2020-01-13 |