MAUDE Adverse Event Report: PRO MED INSTRUMENTS GMBH DORO® BASE UNIT; DORO® ADJUSTABLE BASE UNIT

Model Number	3001-00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was inspected and tested.Within this inspection functional testing and visual inspection was made.It is not assumed that the bent cylinder pin and the difficult-to-remove transitional member have contributed to the incident.Since the customer reported that the locking lever popped open after closure, we assume that the locking lever was not fully closed, since it is not possible for the lever to pop open when it is fully engaged.As a cracking sound could be heard when the locking lever is closed, we suspect that this sound could have been misinterpreted as feedback for the final engagement of the locking lever.However, the user is informed in the instructions for use that he must ensure that all locking mechanisms are locked before use, as is the case with the locking lever of the base unit, the opening of which, according to the feedback, led to the opening of the system and the resulting falling out of the patient's head.No injury was reported, but as there was a potential risk reported, we decided to report this case.
Event or Problem Description
Customer informed us on the (b)(6) that one of our products was involved in a case in which the patient's head fell out of the headrest system, because the locking lever of the system's base unit jumped open after closing.It was required catching the patient's head to prevent it from falling further.
Additional Manufacturer Narrative
Udi related data quality updates only.The following information is being corrected/supplemented due to discrepancies between data submitted in the previous report(s) and data submitted to the gudid: d1, f7.

• Brand Name: DORO® BASE UNIT
• Common Device Name: DORO® ADJUSTABLE BASE UNIT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 17963181
• Report Number: 3003923579-2023-00025
• Device Sequence Number: 6800097
• Product Code: HBL
• UDI-Device Identifier: 04250435500019
• UDI-Public: 04250435500019
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3001-00
• Device Catalogue Number: 3001-00
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/21/2023
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 09/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown