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B.BRAUN 8713145URecalls & reported problems

B. Braun Medical Inc. · SpaceCover Comfort · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963716783), received between May 8, 2023 and May 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Alarm System1
  • Failure to Power Up1
  • Temperature Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 8, 2023Device Alarm System; Failure to Power Up; Temperature Problem; Device Alarm System; Failure to Power Up; Temperature Problem

    AS REPORTED BY THE USER FACILITY: COVER - NOT FUNCTIONING, BLINKING RED LIGHT, AND SMOKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16885118 ↗

Other Pump, infusion devices

All Pump, infusion devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.