MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGIC MONITORING SYSTEMS

Model Number MS25755

Device Problem Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that: when the nurse was walking by the central charger a m300 ¿[battery] exploded and caught on fire" in the charger (i confirmed it was the central 10 dock charger) and was emanating black smoke¿ ¿ there ¿was shrapnel¿ on the floor.There was no patient involvement, however it was conveyed by the risk manager that the nurse was burned (a pin-point) on the hand.Additionally, the m300 next to the one that caught on fire was also damaged.As per the biomed, there was no evacuation nor was the fire department - it was contained by the staff.Quality contacted the risk manager and the following is a summary to date of the information received from the incident: called to rm: (b)(6) | 2 m300 | 1 cc charger : the m300 battery exploded sending debris all over the room quality just learned this (b)(6) not the m300 entirely.The m300 next to the one that exploded was also damaged.The rm words were "it was like a bomb going off" the nurse was burned on her hand - a "pin point burn", per rm, (b)(6).The floor and countertop were both burned.All m300s were removed from service as (b)(6) is requesting they all be pm'd before returning to service.The m300s were pm's in (b)(6) 2021 per rm, (b)(6).The devices are not service by draeger but by 3rd party isometrix (?) (b)(6) confirming this.Dennis has agreed to release the devices upon replacement of his order placed by (b)(6) with rma/return label requested.Once (b)(6) (draeger, tsr) was onsite (b)(6) he was able to look at two additional m300 which were pm¿d in (b)(6) 2021 both units have rd batteries in them and not draeger batteries.The risk manager and the biomed have additional photos which will be released soon for the investigation.The biomed who services the unit has also written up his report and will make that available once the hospital releases him to do so.The customer purchases there replacement parts from parts source.No adverse patient impact was reported.

Manufacturer Narrative

The returned material confirmed the reported issue where the m300 in question was damaged with secondary superficial damage to the charging stations and the neighboring m300 where the outside of the devices had black residue.The charging station and neighboring m300 were tested and confirmed to be fully functional.The customer stated there was use of non-draeger batteries in their m300 units from rd batteries.The complainant verified with the 3rd party biomed that was used by the customer to service the m300 units who stated they used draeger and non-draeger batteries in the service kits and was not able to confirm which battery was in the m300 in question.The returned material was sent to engineering for evaluation who concluded the battery itself was dented in multiple places which resulted in the explosion though the root cause as to how the battery was damaged could not be confirmed.The ifu states to "never use cables or accessories that appear cracked, worn, or damaged in any way.Doing so may compromise performance or put the patient at risk".No further issues have been reported.This is an isolated case.

Event Description

It was reported that: when the nurse was walking by the central charger a m300 ¿[battery] exploded and caught on fire" in the charger (i confirmed it was the central [10 dock] charger) and was emanating black smoke¿ ¿ there ¿was shrapnel¿ on the floor.There was no patient involvement, however it was conveyed by the risk manager that the nurse was burned (a pin-point) on the hand.Additionally, the m300 next to the one that caught on fire was also damaged.As per the biomed, there was no evacuation nor was the fire department - it was contained by the staff.Quality contacted the risk manager and the following is a summary to date of the information received from the incident: called to rm: (b)(6) | 2 m300 | 1 cc charger : 1.The m300 battery exploded sending debris all over the room - quality just learned this 10/25 - not the m300 entirely.2.The m300 next to the one that exploded was also damaged.3.The rm words were "it was like a bomb going off" the nurse was burned on her hand - a "pin point burn", per (b)(6).4.The floor and countertop were both burned.5.All m300s were removed from service as (b)(6) is requesting they all be pm'd before returning to service.6.The m300s were pm's in (b)(6) 2021 per (b)(6).The devices are not service by draeger but by 3rd party isometrix (?) - (b)(6) confirming this.7.(b)(6) has agreed to release the devices upon replacement of his - order placed by (b)(6) - with rma/return label requested.8.Once (b)(6) (draeger, tsr) was onsite (b)(6) he was able to look at two additional m300 which were pm¿d in (b)(6) 2021 ¿ both units have rd batteries in them and not draeger batteries - photo attached.9.The risk manager and the biomed have additional photos which will be released soon for the investigation.10.The biomed who services the unit has also written up his report and will make that available once the hospital releases him to do so.11.The customer purchases there replacement parts from parts source.No adverse patient impact was reported.

• Brand Name: INFINITY M300
• Type of Device: PHYSIOLOGIC MONITORING SYSTEMS
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 12849013
• MDR Text Key: 282191217
• Report Number: 1220063-2021-00032
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: 04049098048989
• Combination Product (y/n): N
• PMA/PMN Number: K151860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

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: MS25755
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/04/2014
• 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
• Treatment: NA.; NA.