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

Model Number 3001-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  Injury  

Event Description

Customer informed us on the 6th of september 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.

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.

• Brand Name: DORO® ADJUSTABLE BASE UNIT
• Type of Device: DORO® ADJUSTABLE BASE UNIT
• Manufacturer (Section D): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer (Section G): PRO MED INSTRUMENTS GMBH; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• Manufacturer Contact: nicholas preissler ; boetzinger str. 86; freiburg, baden-wuerttemberg 79111 ; GM 79111
• MDR Report Key: 17963182
• MDR Text Key: 326004652
• Report Number: 3003923584-2023-00025
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 04250435500019
• UDI-Public: 04250435500019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3001-00
• Device Catalogue Number: 3001-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other