VASOPRESS DIGITAL MINI PUMP N/A VP500DM

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number0001526350-2020-00055
MDR Report Key9582810
Report SourceUSER FACILITY
Date Received2020-01-13
Date of Report2020-01-13
Date Mfgr Received2019-12-19
Date Added to Maude2020-01-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DRIVE
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1ZIMMER SURGICAL, INC.
Manufacturer Street200 WEST OHIO AVENUE
Manufacturer CityDOVER OH 44622
Manufacturer CountryUS
Manufacturer Postal Code44622
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameVASOPRESS DIGITAL MINI PUMP
Generic NameSLEEVE, LIMB, COMPRESSIBLE
Product CodeJOW
Date Received2020-01-13
Returned To Mfg2019-11-07
Model NumberN/A
Catalog NumberVP500DM
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerZIMMER SURGICAL, INC.
Manufacturer Address200 WEST OHIO AVENUE DOVER OH 44622 US 44622


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

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