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

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

A company field service engineer visited the hospital and evaluated the device.He was informed that the connecting screw inside the knob broke shortly after a patient monitor (about 5kg) was clamped on the knob.Maquet (b)(4) conducted the following initial investigation after receiving the complaint: - the knob and monitor arm are provided by our qualified supplier, delivered by maquet and installed on site with the maquet modutec device.The relevant records related to the broken knob were reviewed.No nonconformity was recorded before delivery, during unpacking and during installation.- the complaint data since year 2008 was reviewed.No similar failure was reported out of around (b)(4) itd knobs delivered.- the supplier reviewed the design history of this knob.This knob passed the vertical load test with an 8x safety factors (total 80kg) and the horizontal load test with a 6x safety factors (60kg) according to en 60601-1.It also passed the life-cycle test (10000 cycles) under maximum load, simulating 10 years of use.The design of the knob was therefore demonstrated to be sufficiently robust.The broken knob was replaced by a new one.No issue was reported by the hospital.The defective sample will be returned to the supplier for further analysis.A follow-up report will be submitted when additional information becomes available.

Event Description

On (b)(6) 2017, a hospital in (b)(6) reported that the knob used with the monitor arm broke and fell on the floor.No injury or death was reported.No similar complaint was reported so far.(b)(4).

Manufacturer Narrative

Maquet (b)(4) did further investigation together with the supplier base on the returned defective sample.Here is the investigation summary: the returned defective knob was observed with unusual obvious damage in the surface where the screw was mounted, which is unlikely from the normal use, but from the unintended heavy force from horizontal direction.The material at the cracked section of the screw was found very homogenous and voidless, rather than multiple layers/ ladder-shaped, and also no visible nonmetallic material was observed, which indicated the crack was improbably caused by the material issue according to the principle of metallographic analysis.In addition, the design of the knob has been verified that it conforms to mechanical strength according to en 60601-1 by loading testing with 6x safety factors (60kg) at horizontal direction.With above information, it could be concluded that the knob crack is very likely caused by the unintended heavy force from horizontal direction.This is the only one case reported from this (b)(6) hospital out of 10,000 delivery in worldwide, we believe it¿s an isolated case from unintended use.No further corrective action is taken except the replacement of the damaged knob at this hospital.

Event Description

Manufacturer reference# (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: 6493239
• MDR Text Key: 73023465
• Report Number: 3007417753-2017-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2015
• 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