MAUDE Adverse Event Report: OHMEDA MEDICAL ROTATING IV POLE; STAND, INFUSION

Model Number 2082844-001

Device Problems Detachment Of Device Component (1104); Device Tipped Over (2589)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event was due to excessive tap drill depth resulting in the thin wall section of the block bracket assembly which is the bracket that attaches the pole to the bed.A fall of the rotating iv pole could result in an injury to a bystander holding the patient or to the operator.Ge healthcare will initiate and report a field modification for this issue per 21 cfr 806.The gehc internal field modification number is (b)(4).Patient information could not be obtained after multiple attempts.Attempts were made as follows: 12/1/2017 email and phone call, 12/4/2017 phone call, 12/5/2017 email and phone call.

Event Description

The customer reported the rotating iv pole broke away from the bed station while in use with a patient.The nurse was able to catch the pole before it fell over.There was no reported patient injury.

• Brand Name: ROTATING IV POLE
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): OHMEDA MEDICAL; 8880 gorman rd; laurel, MD
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7099469
• MDR Text Key: 94804452
• Report Number: 1121732-2017-00002
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2082844-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: FMI 32059
• Patient Sequence Number: 1