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 Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event was reported by a costumer from usa: "2 sapphire power supply has problems.Reported as a complaint and customer already received a replacement.Power supply has no output and wont charge.The other power supply has a broken case.Problem came from the family and maternity center.No reported patient involvement.Advised by a sales representative to report the problem.Patient involvement: no death / serious injury: no.Human harm: no.Delay in therapy: unknown.Need for medical intervention: unknown." additional information was received on (b)(6) 2015: "power supply was not twisted-not sure if it was dropped on the floor.It seem to be glued together, taped it and it still worked, just broken." after re-evaluated before closing, the event marked as reportable on (b)(6) 2015.

• 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: 5284550
• MDR Text Key: 33110776
• Report Number: 3010293992-2015-00220
• 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: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Biomedical Engineer
• Device Catalogue Number: 15072-000-0005
• Device Lot Number: 5014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/15/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• 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: Unknown
• Patient Sequence Number: 1