MAUDE Adverse Event Report: AESCULAP AG AESCULAP AEOS; OR TECHNOLOGY NEURO

Model Number	PV010
Medical Device Problem Codes	Computer Software Problem (1112); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with pv010 - aesculap aeos.According to the complaint description, the aeos system generated rebalance (20 seconds) happens every time aeos is moved into "drape" or "drape standby." in the past, the longer rebalance would only occur when the system was initially moved into "drape" position.The longer rebalance especially when bringing the system into surgery causes a delay until the system completes the action.The doctor completed the case with aeos and the patient woke up from anesthesia normally.There was no described patient harm.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.

• Brand Name: AESCULAP AEOS
• Common Device Name: OR TECHNOLOGY NEURO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11457003
• Report Number: 9610612-2021-00146
• Device Sequence Number: 3678752
• Product Code: FSO
• UDI-Device Identifier: 04046955206742
• UDI-Public: 4046955206742
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: PV010
• Device Catalogue Number: PV010
• Device Lot Number: 52620623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1