MAUDE Adverse Event Report: Q CORE MEDICAL LTD. POWER SUPPLY

Catalog Number 05020-150-0160-00

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Distributor information: (b)(4).Q core medical ltd (manufacturer) is submitting the report on behalf of (b)(4).

Event Description

The event was reported by a customer from usa: "one of power cords for our sapphire epidural pumps was ripped out of the wall breaking off the metal prong.These units have various prongs that slide in and out of the plug itself.Delay in therapy: unknown.Need for medical intervention: unknown.Death / serious injury: no.".

• Brand Name: POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; yad haruzim st. 29; netanya, 42505 29; IS 4250529
• Manufacturer Contact: judith antler ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 732388861
• MDR Report Key: 5375582
• MDR Text Key: 36250891
• Report Number: 3010293992-2016-00019
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 05020-150-0160-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1