MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG UNKNOWN_COMMUNICATION_PRODUCT

Catalog Number UNK_SCC

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2015

Event Type  Injury  

Manufacturer Narrative

It was reported from the customer¿s insurance company that an employee was allegedly injured while moving the boom monitors when the arm reportedly came out of the ceiling.No additional information was reported as such any additional information will be provided in a supplemental.Customer has not responded to requests.

Event Description

It was reported that while an employee was moving the boom away from a patient, the arm allegedly came out of the ceiling.There was no reported injury to the patient.The customer's insurance company sent correspondence alleging that the employee was injured.

Manufacturer Narrative

There has been corrected data updates made to the following fields: outcomes attributed to ae, manufacturer entity, reporting entity, manufacturing site for devices, reporting contact, clinical signs, health impact, device, component, method, and conclusion code grids.

Event Description

It was reported that while an employee was moving the boom away from a patient, the arm allegedly came out of the ceiling.There was no reported injury to the patient.The customer's insurance company sent correspondence alleging that the employee was injured.

• Brand Name: UNKNOWN_COMMUNICATION_PRODUCT
• Type of Device: UNKNOWN
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen SC 78532 ; GM 78532
• MDR Report Key: 5688907
• MDR Text Key: 46214636
• Report Number: 0001220865-2016-00016
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SCC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other