MAUDE Adverse Event Report: HOLGER ULLRICH LI-ION BATTERY WITH CHARGING INDICATION; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problems Nausea (1970); No Information (3190)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.

Event Description

The following was reported to us.In at least three cases the battery of a transporter malfunctioned.Because the battery did not work, the transporters could not be moved to trendlenburg position.Due to this malfunction mayor complications occurred in at least three cases.Further information concerning the nature of these incidents was requested from the clinic, but not yet received.Manufacturer reference# (b)(4).

Event Description

Manufacturer reference # (b)(4).The event date was accidently set to the (b)(6) 2021.The year was wrong.This took place in 2020.

Manufacturer Narrative

Manufacturer reference # (b)(4).The event date was accidently set to the (b)(6) 2021.The year was wrong.This took place in 2020.

Manufacturer Narrative

According to a statement from the clinic, the batteries were charged.The green led which indicates the charging state was on.After the incidents occurred it was tried to charge the batteries again.This was not possible.On the 24th of june 2020 the batteries were swapped.After this swap, no more problems occurred.That is why we assume that the malfunction is limited to the batteries and not related to other products or a special kind of use.The batteries were returned to the manufacturing site.Since a deep discharge occurred, a root cause investigation was not possible.We have requested the records of final inspection from the supplier.The investigation of this records resulted in no indications.If this malfunction reoccurs in the future, we will if possible, pick up the batteries immediately.This way an investigation can be performed before the batteries are in the deep discharge state.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The following information was received concerning the nature of the incidents.Via a user report we were informed that batteries which are used in a transporter have failed.The transporter is used to transport patients and can be adjusted.Since the batteries failed the transporters could not be adjusted.One patient was prepared for surgery.He complained about nausea.Next it was tried to move the transporter to the shock position (head down).This was not possible.The patients legs were lifted.Neither the treatment of the patient nor the hospital stay were prolonged.No subsequent damage occurred.The clinic reported complications in three cases.The event dates for these cases were "mid to end of may 2020".The range could not be narrowed down further.According to a statement from the clinic, only fully charged batteries were used.The led, which indicates the charging state of the batteries, was green.This indicates the battery is fully charged.Afterwards it was not possible to determine the serial numbers of the batteries which were used when the three incidents occurred.The serial numbers could be narrowed down to the following range: (b)(6).Manufacturer reference # (b)(4).

• Brand Name: LI-ION BATTERY WITH CHARGING INDICATION
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10127944
• MDR Text Key: 194310334
• Report Number: 8010652-2020-00012
• Device Sequence Number: 1
• Product Code: FQO
• 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
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100975A0 - LI-ION BATTERY WITH CHARGING INDICATION
• Device Catalogue Number: 100975A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other