MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS BATTERY 14.8V, 6.3 AH LI-ION BATTERY; DEFIBRILLATOR

Model Number	M3538A
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the battery is defective.There was no patient involvement.

• Brand Name: BATTERY 14.8V, 6.3 AH LI-ION BATTERY
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9186578
• Report Number: 1218950-2019-07790
• Device Sequence Number: 11570922
• Product Code: MKJ
• UDI-Device Identifier: 00884838002791
• UDI-Public: (01)00884838002791
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K031187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: M3538A
• Device Catalogue Number: 989803129011
• Device Lot Number: 19039-0180-P
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1