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

Model Number POWER SUPPLY

Device Problem Break (1069)

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

Event Date 05/13/2015

Event Type  malfunction  

Event Description

The event was reported by a customer from usa: "we have been experiencing an extensive failure rate on the domestic version of sapphire external power supplies.In particular, the plastic shells housing the electronics easily separates (creating a serious electrical safety hazard).Also, the cable in the low-voltage power plug separates with little effort from the connector shell (see attached pictures).At (b)(6) alone, we have experienced a failure rate of 40% (20/50) since go-live.Upon close examination, the power pack shell does not have an adequate bonding agent.In other designs, an epoxy is used to fill the voids, bond components, and transmit heat to outer surfaces.The low-voltage power plug lacks adequate friction in the locking ring associated with the connector shell.Some of the failures could be attributed to careless usage.But when compared to failure rates of other devices having external power packs, the sapphire failure rate is beyond anything we have seen before.Delay in therapy: unknown.Need for medical intervention: unknown.Human harm: no.".

Manufacturer Narrative

(b)(4).Q core medical ltd (manufacturer) is reporting on behalf of hospira.

• Brand Name: Q CORE POWER SUPPLY
• Type of Device: POWER SUPPLY
• Manufacturer (Section D): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 4250 529; IS 4250529
• Manufacturer (Section G): Q CORE MEDICAL LTD.; 29 yad haruzim st.; netanya, 4250 529; IS 4250529
• Manufacturer Contact: judith antler ; 29 yad haruzim st.; netanya, 42505-29 ; IS 4250529 ; 0732388827
• MDR Report Key: 4975841
• MDR Text Key: 20362816
• Report Number: 3010293992-2015-00144
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/17/2015

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: Health Professional
• Device Model Number: POWER SUPPLY
• Device Catalogue Number: 15072-000-0005-ASM
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/17/2015
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 08/06/2015
• 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: Reuse
• Patient Sequence Number: 1