MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568370955

Device Problems Crack (1135); Naturally Worn (2988)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 21st september 2020 getinge became aware of an issue with one of surgical lights- hled.As it was stated customer alleged about cracks on the acrylic cover of the headlight and about handle holder and also about not working wall dimmer.Photographic evidence of the issue was in line with alleged issue and moreover revealed that due to mentioned cracks particles were missing on the cover and also on the layer of the keypad.No information about patient involvement was provided however we decided to report this case in abundance of caution as any particles falling off into sterile field may cause contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

Manufacturer's reference number: (b)(4).

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of surgical lights- hled.As it was stated customer alleged about cracks on the acrylic cover and due to mentioned cracks particles were missing on the cover.Also on the keypad paint chipping and missing layers were observed.No information about patient involvement was provided however we decided to report this case in abundance of caution as any particles falling off into sterile field may cause contamination.Manufacturer's reference number (b)(4).

Manufacturer Narrative

There is a correction of the field 'describe event or a problem' (b5): previous: 'on (b)(6) 2020 getinge became aware of an issue with one of surgical lights- hled.As it was stated customer alleged about cracks on the acrylic cover of the headlight and about handle holder and also about not working wall dimmer.Photographic evidence of the issue was in line with alleged issue and moreover revealed that due to mentioned cracks particles were missing on the cover and also on the layer of the keypad.No information about patient involvement was provided however we decided to report this case in abundance of caution as any particles falling off into sterile field may cause contamination.Manufacturer's reference number (b)(4).Corrected: 'on (b)(6) 2020 getinge became aware of an issue with one of surgical lights- hled.As it was stated customer alleged about cracks on the acrylic cover and due to mentioned cracks particles were missing on the cover.Also on the keypad paint chipping and missing layers were observed.No information about patient involvement was provided however we decided to report this case in abundance of caution as any particles falling off into sterile field may cause contamination.Manufacturer's reference number (b)(4).Conclusion: on (b)(6) 2020 getinge became aware of an issue with one of surgical lights- hled.As it was stated there was paint chipping and missing layers on the keypad and the cracks of the plastic covers, which resulted in missing particles.There was no injury reported however, we decided to report the issue based on the potential as any parts or particles falling off may lead to the surgical field contamination.The device involved in the event is hled 300/700 combination.The serial number of the device is ar20024 and catalog number is ard568370955.The unit was manufactured on (b)(6) 2012.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to described event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that the reported scenario for the keypad issues is a single isolated event on hled devices and for cracked cover it is the second reportable case related to cracks on cover of hled.As it was confirmed by subject matter experts from the manufacturing site the most likely root cause of the keypad missing layers is normal wear at this location.The user manual mentions to check that the keypad is in good condition.As soon as a default is noticed on the keypad tape, its replacement must be performed.The tape is available as spare part.Situation occurrence is related to use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.Regarding keypad paint chipping: the paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.Cracked cover of hled300 was probably exposed to constrained area and/or cleaning product.These facts indicate that cleaning agent residues may have a negative reaction on the plastic surfaces and leads to its degradation.The concentration of chemical products, the presence of agent residual on the disinfected surfaces are probably the main factors leading to the deterioration of surfaces.Cracked cover of hled700 was most likely caused by the mechanical damage.If the described failures occurs, the user can visually detect it during the daily checks to be performed prior to each use, as recommended in the user manual.We believe that devices in the market are performing correctly overall.We also find the issue as highly detectable during daily visual inspection which is an important step given in the user manual.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 10634402
• MDR Text Key: 209995065
• Report Number: 9710055-2020-00399
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2021

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 Model Number: ARD568370955
• Device Catalogue Number: ARD568370955
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 11/09/2020; 03/09/2021
• Supplement Dates FDA Received: 11/06/2020; 12/04/2020; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1