MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LITTLETON) O-ARM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Catalog Number BI-700-00020 O-ARM STAND

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

The machine was being used to scan the patient during surgery when it stopped working.The operator was unable to open the jaw on the machine so it could be pulled away from the patient.Operator attempted to manually open the jaw using the supplied wrench tool which is supposed to turn a gear mechanism.The fitting on the machine then snapped off.Engineering staff were eventually able to re-engage the snapped off part enough to open the jaw and free the machine from around the patient.There was about a 1 hour delay in the procedure caused by the problem, during which the patient was under anesthesia.This same machine had a similar malfunction about 10 days previous where the jaw had to be manually opened following a hardware failure during a scan.Manufacturer service rep replaced some parts following the first failure.If the jaw was unable to be opened, it would be extremely difficult and dangerous to attempt moving the patient off the surgical bed.Opening the jaw manually seems to require an excessive amount of force on the wrench tool and the fitting is recessed which makes it difficult to use without applying a large bending force on the fitting.
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manufacturer response for portable ct scanner, (brand not provided) (per site reporter)
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manufacturer service personnel repaired the machine.

• Brand Name: O-ARM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• MDR Report Key: 9488540
• MDR Text Key: 171816922
• Report Number: 9488540
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2019

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 Catalogue Number: BI-700-00020 O-ARM STAND
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2019
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA