MAUDE Adverse Event Report: XINSPOWER TECHNOLOGY CO LTD INFUSION PUMP CHARGER; PUMP, INFUSION, ENTERAL

Model Number A122-0651800UD

Device Problems Failure to Power Up (1476); Defective Device (2588); Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2020

Event Type  Injury  

Event Description

Dangerous electronic device; purchased on (b)(6) from zk2020usa a battery charger for covidien kangaroo joey infusion pump.Seller claimed the charger matches technical specifications for the infusion pump but it does not.The charger uses a different voltage and amperage than the pump.The infusion system sustained an unknown level of damage and will need to be evaluated using a biomedical company issued charger.The charger received is a cheap (b)(6) knock off with incorrect specifications.Photographs show the fake label that shows an output voltage of 1249v (which would make the device a high voltage appliance regulated by high voltage laws) the second photograph shows the actual charging devices voltage which is 6.5v at 1800ma which is incorrect for the infusion device.Reference values original charger from manufacturer voltage 5v amperage 2.4a no actual electrical test was conducted.The fake charger failed to power the equipment.Amperage far below technical specifications of original charger.Fda safety report id# (b)(4).

• Brand Name: INFUSION PUMP CHARGER
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): XINSPOWER TECHNOLOGY CO LTD ; huangpu shuiku road no.3; shajing street, the a bldg ; baoan district, shenzhen ; CH
• MDR Report Key: 10482518
• MDR Text Key: 205651139
• Report Number: MW5096375
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A122-0651800UD
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 52