Babytherm 8010 System 2M22380Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048675017097), received between Jun 25, 2024 and Nov 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Accessory Incompatible” (1 report).

1 other recall cover devices cleared under the same FDA submission (K971198); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2024Degraded; Material Fragmentation; Structural Problem; Detachment of Device or Device Component; Degraded; Material Fragmentation; Structural Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON THE EVENING OF (B)(6) 2024, AROUND 8:00 PM, THE PHOTOTHERAPY LAMP OF THE AFFECTED DEVICE, BABYTHERM 8010, WAS SWITCHED OFF AFTER COMPLETION OF THE PHOTOTHERAPY CYCLE ON THE NEWBORN. DURING THE SWITCH-OFF, ONE OF 6 LAMPS (HALOGEN LAMP?) EXPLODED WITH A LOUD BANG AND NUMEROUS SMALL AND TINY GLASS SPLINTERS FELL ON THE NEWBORN LYING IN BED. THE NEWBORN SUFFERED BURNS FROM THE HOT GLASS SPLINTERS, IT WAS WEARING PROTECTIVE GOGGLES AND ITS MOUTH WAS CLOSED.

  Patient problems: Burn(s)

  MAUDE report 20639103 ↗
• InjuryJun 25, 2024Accessory Incompatible; Fracture; Unexpected Therapeutic Results; Accessory Incompatible; Fracture; Unexpected Therapeutic Results

  IT WAS REPORTED THAT A LAMP BULB HAD BROKEN IN THE INCUBATOR THAT WAS BEING USED FOR PHOTOTHERAPY. THE GLASS IN SMALL SHARDS FELL INSIDE THE OPEN INCUBATOR. THE PATIENT WAS IMMEDIATELY REMOVED FROM THE INCUBATOR. SEVERAL SHARDS OF GLASS WERE FOUND ON THE SKIN AND IN THE PATIENT'S HAIR AND A SMALL BLISTER FILLED WITH FLUID WAS FOUND ON THE RIGHT SHOULDER WHICH WAS ASSESSED TO BE A THIRD-DEGREE BURN. NO FRAGMENTS OF SUTURE WERE OBSERVED IN THE ORAL CAVITY AND CONJUNCTIVAL SACS. CLEAN FOOD WAS ASPIRATED FROM THE STOMACH. THE BLISTER WAS CARED FOR WITH MICRODACIN. THE PATIENT WAS BATHED AND PLACED INTO ANOTHER INCUBATOR. THE PHOTOTHERAPY WAS DISCONTINUED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19603664 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K971198. One submission often covers many models, so check the product and lot details in each record.

• Z-2295-2016 · Jun 22, 2016 · Terminated
  Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: