BIS 186-0195-NKRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521129788), received between Jun 16, 2020 and Apr 28, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K072286); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Incorrect Measurement; Device Damaged Prior to Use; Material Split, Cut or Torn; Incorrect Measurement; Device Damaged Prior to Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PRE-OPERATIVE PREPARATIONS, A MODULE EXPERIENCED A CRACK IN THE HOST CABLE SLEEVE, INTERMITTENT READINGS, AND DAMAGE TO THE REAR CLAMP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922784 ↗
• MalfunctionMar 18, 2025Incorrect Measurement; Device Damaged Prior to Use; Material Split, Cut or Torn; Incorrect Measurement; Device Damaged Prior to Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT PRIOR TO USE IN THE OPERATING ROOM, THERE WERE ISSUES WITH LOW WAVEFORM SENSITIVITY CAUSING INTERMITTENT READINGS, EXTERIOR HOUSING DETERIORATION, AND A DEFECTIVE HOST CABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634880 ↗
• MalfunctionJan 17, 2025Incorrect Measurement; Unable to Obtain Readings; Device Damaged Prior to Use; Material Split, Cut or Torn; Incorrect Measurement; Unable to Obtain Readings; Device Damaged Prior to Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WERE ISSUES WITH A DEVICE DUE TO NOISE CONTAMINATION FROM A FAULTY RELAY CABLE RESULTING TO NO READINGS, A CRACK IN THE HOST CABLE SLEEVE, AND A DAMAGED REAR CLIP. THE FAILURE WAS OBSERVED IN THE OPERATING ROOM DURING PRE-OPERATIVE PREPARATIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182210 ↗
• MalfunctionNov 7, 2024Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn; Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE HAD A POOR MEASUREMENTS BUT WAS NOT ABLE TO PROVIDE ANY DETAILS, WITH DAMAGED HOST CABLE AND REAR RUBBER CLIP. THE PIC WAS ALSO DETERIORATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627750 ↗
• MalfunctionNov 7, 2024Incorrect Measurement; Incorrect Measurement

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD NO CORRECT VALUES/READING AND THERE WERE SUDDEN UPWARD SWINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20627693 ↗
• MalfunctionNov 6, 2024High Readings; Material Split, Cut or Torn; High Readings; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD UNSTABLE OPERATION WITH HIGH READING, AND THE HOST CABLE HAD A CRACKED IN THE SLEEVE. FAILURE WAS ISOLATED TO THE MODULE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623435 ↗
• MalfunctionNov 5, 2024High impedance; Device Damaged Prior to Use; High Readings; High impedance; Device Damaged Prior to Use; High Readings

  ACCORDING TO THE REPORTER, PRIOR TO USE, UNIT IMPEDANCE WAS TOO HIGH TO MEASURE. UNIT HOUSING AND RUBBER AROUND THE REAR CLAMP WAS DETERIORATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613488 ↗
• MalfunctionJul 11, 2023Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HOST CABLE WAS DISCONNECTED AND PIC WAS DETERIORATED. REAR CLIP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297676 ↗
• MalfunctionJul 29, 2022Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn; Device Damaged Prior to Use; Low Readings; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRE - OPERATIVELY, THE DEVICE GAVE POOR MEASUREMENTS / READINGS. THE RELAY CABLE WAS DETERIORATED AND THE GASKET WAS ALSO FOUND POPPING OUT. THE MODULE WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135895 ↗
• InjuryDec 14, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING SURGICAL PROCEDURE, THE DEVICE HAD AN INCIDENT TO PATIENT AWARENESS. THE PATIENT SAID THAT HE HAD A MEMORY DURING THE SURGERY. FROM THE HOSPITAL INVESTIGATION, THE CAUSE OF INADEQUATE SEDATION WAS PROBABLY THAT THE ANAESTHETIC DRUG DESFLURANE WAS NOT FLOWED INTO PATIENT DUE TO THE INSUFFICIENT CONNECTION BETWEEN THE VAPORIZER AND ANESTHETIC CIRCUIT. BASED ON THIS FACT, THE PATIENT WAS LIKELY AWAKE DURING THE SURGERY, BUT THE VALUE ON THE DEVICE WAS SHOWN AROUND 40. SURGICAL OPERATION ITSELF WAS COMPLETED SUCCESSFULLY AND NO PHYSICAL HEALTH HAZARDS BUT HAD A CONCERN ABOUT THE IMPACT ON MENTAL SIDE OF THE PATIENT.

  Patient problems: Awareness During Anesthesia

  MAUDE report 11003762 ↗
• MalfunctionJun 16, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE UNIT WAVEFORM WAS UNSTABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10159051 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072286. One submission often covers many models, so check the product and lot details in each record.

• Z-2958-2018 · Jul 26, 2018 · Open, Classified
  Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319