MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS WIRELESS GATING & WIRELESS ECG/SPO2 MODULES

Model Number	453564185591
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to philips that the battery shorted out causing damage to the ecg module.The device was not in use on a patient at the time of event, there was no patient involvement.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The alleged malfunctioning battery was requested for evaluation, but the attempt was unsuccessful.If additional information is later obtained, the complaint will be reopened.The customer ordered a replacement part to resolve the issue.Section d serial number was corrected h3 other text : see h10.

• Brand Name: WIRELESS GATING & WIRELESS ECG/SPO2 MODULES
• Common Device Name: WIRELESS GATING & WIRELESS ECG/SPO2 MODULES
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12703450
• Report Number: 1051786-2021-10065
• Device Sequence Number: 11119713
• Product Code: MWI
• UDI-Device Identifier: 00884838046795
• UDI-Public: 00884838046795
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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: Other
• Device Model Number: 453564185591
• Device Catalogue Number: 453564185591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown