MAUDE Adverse Event Report: Q CORE MEDICAL LTD. POWER SUPPLY (FIXED HEADS )

Catalog Number 15072-000-0005

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: "receive a call from (b)(6) who have 25 power supply and 6 of them are breaking lot # 4914, ref (b)(4).No patient involvement, no human harm and no delay in therapy.Event date provided by customer was two months ago.Delay in therapy: no.Need for medical intervention: no.Patient involvement: no.Human harm: no."additional information was received on dec 24th, 2015: "which part of the power supply is broken, the plastic part which connects to the pumps power socket or the pins connected to the wall outlet? the end that connects to the pump on most of this pumps.We did just receive an additional ps that the plastic at the wall is broke please provide full details regarding the circumstances which led to the power supply breakage: i don't have these details.Broken cables just arrived in the office with no names attached.When asking how it happened, they couldn't identify a specific cause, but in most cases was related to moving the pump from patient room through decontamination and back to clean room a.During insertion/disconnection of the power supply? i do have 1 case where the prongs were still in the pump and the black casing was broke.B.Was a splitter used or was it connected directly to the pump? it was connected to the craddle.C.Was it twisted? does not appear to have been in the cases we have.D.Was it hard to connect/disconnect it from the pump? no.E.Was it dropped or left on the floor? no, it was not in any of the cases identified f.Who connected/disconnected the power supply when the breakage occurred (staff member/patient/bio-med/other)? could not identify any 1 specific department, speculating that it happened after patient use between removal from room and the clean room was an alternative power supply tested in order to charge the pump? in all cases, the pump still took a charge.A.If so did the pump charge with the alternative power supply? yes.".

• Brand Name: POWER SUPPLY (FIXED HEADS )
• Type of Device: POWER SUPPLY (FIXED HEADS )
• 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: 5379336
• MDR Text Key: 36482769
• Report Number: 3010293992-2016-00024
• 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: 12/23/2015

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: Biomedical Engineer
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 4914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2016
• 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