MAUDE Adverse Event Report: HELENA LU MAQUET; TUBING, PRESSURE AND ACCESSORIES

Model Number MODUTEC

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 2015 03:09 pm (gmt-5:00) added by (b)(4)): a maquet fse (field service engineer) visited the hospital and evaluated the device.Hospital staff had repaired this ceiling pendant by replacing the broken nylon screws before he arrived.Through the fse's investigation on site, he observed that: the cover that fell off was not broken, but had some small scratches on both sides; the surgical lights were in close proximity to that ceiling pendant which might have collided with the ceiling pendants when moving.The fse confirmed that all covers and screws were examined prior to the release of the o.R.To the customer 4 years ago during installation; everything was in place and there were no issues at that time.Maquet (b)(4) reviewed the design of the motor cover connection, and it passed impact resistance test according to ul 60601.Based on above, maquet believes that the or staff failed to observe the surroundings while rotating the pendant or surgical lights, which caused a collision between each other and broke the mounting screws of the axis cover.Maquet (b)(4) required fse to remind customer to follow the user manual when moving the device.All similar motor covers in this hospital will be checked and secured via spare parts if necessary.

Event Description

Customer reported a plastic axis cover of the modutec power pendant fell off during set up and hit a nurse's head.The patient and nurse were not harmed.(b)(4).

• Brand Name: MAQUET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer (Section G): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer Contact: maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502-4
• MDR Report Key: 5221568
• MDR Text Key: 31400233
• Report Number: 3007417753-2015-01001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUTEC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/21/2015
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1