MAUDE Adverse Event Report: HOLGER ULLRICH BENDABLE HEAD REST,360 RADIOTRANSLUCENT; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100283A0

Device Problem Break (1069)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2020

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

The following was reported.A head rest was mounted to an or table.The patient was laying on the table and his head was on the head rest.The patient was positioned in a trendelenburg position.During the surgery a resuscitation was necessary.While this resuscitation was performed the head rest broke.To avoid harm to the patient, the resuscitation was paused for some seconds to reposition the patient.Afterwards the resuscitation was continued.No injury or death was reported due to the product issue.We were informed on the 6th of october 2020 about an issue with a head rest involved.No description of the incident was provided.On the 29th of october an incident description was provided and the case was assessed to be reportable, since serious injury in case of recurrence cannot be excluded.No injury of the patient was reported to getinge-maquet.

Event Description

N/a.

Manufacturer Narrative

We have requested further information concerning the patients health status several times, but have not received any answers to these requests.We have requested the defective product to investigate it, but not received any reply to these requests or the defective product.It is unknown where exactly the head plate broke.Based on this background we cannot provide a reliable statement concerning the root cause.A review of the complaint database results in "use error" as most probable root cause for complaints for this product model.Among these use errors are: the product was overloaded or dropped or it collided with obstacles when the or table was moved.One possible root cause for the break is that the product might be pre damaged and broke due to the alternating load during the resuscitation.In the instructions for use (ifu) the user warned concerning the risks related to defective products as follows: "warning! risk of injury! faulty or defective products may result in injuries.Before use, check the proper working order and fully functional state of the product.Stop using faulty or defective products and inform the getinge representative." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.H3 other text : device not returned.

• Brand Name: BENDABLE HEAD REST,360 RADIOTRANSLUCENT
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10799639
• MDR Text Key: 215367045
• Report Number: 8010652-2020-00024
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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
• Device Operator: Health Professional
• Device Model Number: 100283A0
• Device Catalogue Number: 100283A0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR