MAUDE Adverse Event Report: HOLGER ULLRICH TRANSPORTER; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 114061C0

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

At time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up/final report will be submitted.(b)(6).

Event Description

The following was reported to us.After a surgery the user tried to transfer the table top 115010de with the patient to the transporter 114061c0.The table top was in the beach chair position and the patient was ventilated.A part of the transporters carrier frame broke and the table top tilted.The patient started to slide.The operating room team tried to support the table and hold the patient.Two persons got strains in their back due to this.The patient is said to be injured, too.We have requested further information concerning the kind of injury, but not received an answer yet.Manufacturer reference# (b)(4).

Event Description

The following was reported to us.After a surgery the user tried to transfer the table top 115010de with the patient to the transporter 114061c0.The table top was in the beach chair position and the patient was ventilated.A part of the transporter carrier frame broke and the table top tilted.The patient started to slide.The or team tried to support the table and hold the patient.Two people got strains of their back due to this.We were initially informed that the patient was also injured.We have since been informed that the patient was not injured.

Manufacturer Narrative

The affected transporter was returned to the factory for further investigation.During the investigation, it was found that one of the two screws connecting the upper part of the transporter to two supports had come loose.Both the supports and the upper part are part of the supporting frame.The storage area is connected to the upper part of the transporter via two interfaces.Since this upper part was no longer connected to both supports, the malfunction described (damage to the support frame) occurred and the table top tilted.The product in question had been in clinical use for over 20 years, so we assume that the screw came loose over time due to wear and tear.The last maintenance was performed in february 2020 by getinge ¿ maquet service technician and no loosened screw was detected.The complete event site name is (b)(6).The complete phone number of the initial reporter is: (b)(6).The correction of a1 patient identifier and b5 describe event or problem fields deems required.This is based on internal evaluation and the additional information that has been received.Previous a1 patient identifier (b)(6).Corrected a1 patient identifier (b)(6).Previous b5 describe event or problem the following was reported to us.After a surgery the user tried to transfer the table top 115010de with the patient to the transporter 114061c0.The table top was in the beach chair position and the patient was ventilated.A part of the transporters carrier frame broke and the table top tilted.The patient started to slide.The or team tried to support the table and hold the patient.Two persons got strains in their back due to this.The patient is said to be injured, too.We have requested further information concerning the kind of injury, but not received an answer yet.Manufacturer reference# (b)(4).Corrected b5 describe event or problem.The following was reported to us.After a surgery the user tried to transfer the table top 115010de with the patient to the transporter 114061c0.The table top was in the beach chair position and the patient was ventilated.A part of the transporter carrier frame broke and the table top tilted.The patient started to slide.The or team tried to support the table and hold the patient.Two people got strains of their back due to this.We were initially informed that the patient was also injured.We have since been informed that the patient was not injured.

• Brand Name: TRANSPORTER
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 12172853
• MDR Text Key: 261682206
• Report Number: 8010652-2021-00024
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 114061C0
• Device Catalogue Number: 114061C0
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Date Device Manufactured: 06/15/1998
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 115010DE UNIVERSAL TABLE TOP; 115010DE UNIVERSAL TABLE TOP
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 90 KG