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Merced,

As I indicated in our verbal conversation earlier, my concerns are following:

1.  By use of non-OEM battery pack (that is not identical to OEM) without written documented specification that indicates it meets or exceeds the OEM specifications of the battery pack originally built into the system would that comprise us to modifying the equipment (illegal) unless we have written OEM documentation allowing for such modification.

2.  Although 3rd party vendor indicates that the voltage ratings and connections are equivalent to the OEM battery pack and they sold 1000s of them, it doesn’t mean there has been validation testing of the charging/discharging rate characteristics between the replacement battery pack and C-arm charging circuit.

a.  Will replacement battery pack operate the same way as the original?

b.  Will replacement battery pack create undue stresses to the charging circuit such as higher than normal charging currents and more heat?

c.  Will replacement battery pack shorten the charging system or cause catastrophic failure to point risk of a fire?

3.  If OEM indicates pack is not equivalent or is considered a modification of the system as they designed it and should we utilize that replacement pack and suffer a failure, or catastrophic failure, then legal liability will solely be the hospital’s for any damages, injury or death to patient or user(s).

Albert

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February 3, 2023 the staff calls that the unit now had a different error and they are DOWN.

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On Monday Merced was instructed to try multiple vendors to find Batteries and we found one now in Florida that has them but it can not be shipped overnight.  Batteries ordered and we proceed to order a second batch from another source.  Then on Tuesday February 7, 2023 Merced goes to check out the unit after consulting with GE that it could be something else causing that error.  He recedes boards and does a battery test.  Batteries checked out fine but on the closer to low side.  Call then goes to escalation.  

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On Monday Merced was instructed to try multiple vendors to find Batteries and we found one now in Florida that has them but it can not be shipped overnight.  Batteries ordered and we proceed to order a second batch from another source.  Then on Tuesday February 7, 2023 Merced goes to check out the unit after consulting with GE that it could be something else causing that error.  He recedes boards and does a battery test.  Batteries checked out fine but on the closer to low side.  Call then goes to escalation.  