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

Catalog Number 15072-112-0003

Device Problem Break (1069)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The event was reported by a customer from usa: i spoke with the customer (b)(6) and he said he has 6 broken power supplies where the upper case of the circuit board that is glued together breaks loose exposing wires in it.He also said that there were incidents of nurses getting shocked because of this issue and he is really frustrated about this.He wants to call the attention of the manufacturer to redesign the power supplies that are having problems.He had already called in 6 power supplies and received replacements and he is reporting another 6 that has the same issue.Patient involvement: yes.Death / serious injury: no.Delay in therapy: unknown.Need for medical intervention: unknown.Additional information was received on nov.11th, 2015: " i just spoke with (b)(6) and he stated that they had several incidents of nurses got shocked when the power supply was damaged.As with the pictures, he said that it was the same with all the broken power supply that he reported.Please don't make another attempt to follow up the same questions.For future ps complaints coming from (b)(6), please call him directly and ask him if the ps complaint being reported is just the same as the previous ps complaint that he sent us.".

• Brand Name: POWER SUPPLY (FIXED HEAD)
• Type of Device: POWER SUPPLY (FIXED HEAD)
• 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: 5267256
• MDR Text Key: 32680220
• Report Number: 3010293992-2015-00212
• 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: 11/09/2015

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: 15072-112-0003
• Device Lot Number: 5014
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2015
• 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