MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTREAM ADULT PADS; DEFIBRILLATOR

Model Number	M3718A
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the m3718a pads were delivered with the same illustration printed on the left and right pads.There was no patient involvement.
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to philips that the m3718a pads were delivered with the same illustration printed on the left and right pads.There was no patient involvement.
Event or Problem Description
It was reported to philips that the m3718a pads were delivered with the same illustration printed on the left and right pads.There was reportedly no patient involvement.The manufacturer's bench repair technician evaluated the device and confirmed the reported problem.The allegation was verified - this adult/child radiotransparent multifunction electrode pads were received with the wrong artwork.On the infant radiotransparent multifunction electrode pads, only the posterior label was represented on both the pads; there was no anterior label illustrated.Similarly, only the sternum label was represented on both adult radiotransparent multifunction electrode pads; there was no apex label illustration.Upon conclusion of the evaluation, it was determined that this was a malfunction of the electrode pads.The pads have been scrapped.A supplier corrective action request has been initiated.An inventory sampling found no defects.The supplier has issued a quality alert to promote awareness.The cause was determined to be assembly error.No further evaluation is warranted at this time.

• Brand Name: HEARTSTREAM ADULT PADS
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11614669
• Report Number: 3030677-2021-10692
• Device Sequence Number: 11552598
• Product Code: MKJ
• UDI-Device Identifier: 00884838002876
• UDI-Public: 00884838002876
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Model Number: M3718A
• Device Catalogue Number: M3718A
• Device Lot Number: 003686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Distributor Facility Aware Date: 03/15/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 09/14/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/30/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1