MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS BATTERY PACK FOR DRAEGER INFINITY DELTA XL ; MONITOR, PHYSIOLOGICAL, PATIENT

Model Number CS-MS-1449MH

Device Problem Nonstandard Device (1420)

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

Event Date 05/04/2018

Event Type  Injury  

Event Description

During a routine inspection of battery packs to be used in draeger siemens pt monitors.We found several lithium ion battery packs produced by (b)(4) to have been built with both old, and recycled lithium-ion cells which puts both pts and medical techs at severe risk of injury due to the potential fire hazard that can occur.We contacted (b)(4) about this issue, and informed them of this problem.They stated that they were not aware as they are simply a relabel-er and not the mfr of the product that they are selling.We felt the issue had been resolved, but recently we found that they are now selling this same product as well as several other batteries intended for medical devices on both (b)(6).((b)(6) should not be selling medical products to the american consumer from a company that is not iso-13485-2016 certified, and more importantly is not registered with the fda).The safety of american pts visiting health care providers, as well as medical industry professionals is at an absolute risk with every one of these unregistered battery packs being sold on line.A (b)(4) company that is not registered with the fda should not be allowed to sell these sub standard medical product on the us market.Especially through chanels that does not allow for proper trace-ability.Someone is going to get seriously hurt due to this (b)(4) company that obviously does not want to follow the same rules and safety procedures that every other fda registered and iso: 13485-2016 certified company is expected to follow in order to guarantee pt safety and proper compliance.A quick check on (b)(6) will show that there is a mass of this unregistered (b)(4) products covering device categories such as pt monitors, ventilators, infusion pumps, scopes, ecg's, and numerous other medical devices.Product was found to have been recycled from old laptop battery packs, and failed a standard capacity test.The individual cells had leftover fishpaper and glued foam from the original laptop battery pack assembly.Also noted were signs when cells had been soldered when it should have been welded.(add'l examples were found to have had the original vinyl shrink wrap removed in an attempt to conceal the true age of the cell which in many cases were 7 to 10 y/o).The maximum shelf life for a lithium ion battery used in a medical device should be no more than 4 yrs, and they should never be recycled out of a different battery pack.Fda safety report id# (b)(4).

• Brand Name: BATTERY PACK FOR DRAEGER INFINITY DELTA XL
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS
• MDR Report Key: 9383288
• MDR Text Key: 168447179
• Report Number: MW5091311
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CS-MS-1449MH
• Device Catalogue Number: MS14490
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention