NA 511.615Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982237613), received between Jul 10, 2018 and Oct 6, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (3 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2020Output below Specifications; Output below Specifications

  IT WAS REPORTED FROM (B)(6) THAT DURING TESTING OF THE DEVICE, IT WAS OBSERVED THAT THE AIR RECIPROCATOR DEVICE HAD LOW PRESSURE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10635625 ↗
• MalfunctionApr 2, 2019Output below Specifications; Output below Specifications

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR OF THE AIR RECIPROCATOR DEVICE WAS NOT FUNCTIONING AND WAS DEFECTIVE. IT WAS NOTED THAT THE MOTOR POWER WAS TOO LOW. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FREQUENCY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2019. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8472983 ↗
• MalfunctionMar 20, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE AIR RECIPROCATOR DEVICE STOPPED WORKING. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436216 ↗
• MalfunctionAug 13, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR RECIPROCATOR DEVICE TRIGGER WAS BLOCKED, JAMMED, HEAVY MOVING AND THE STARTER HANGS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR AIR LEAK, IMMEDIATE STOP AND CHECK THE TRIGGER FUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7776914 ↗
• MalfunctionJul 10, 2018Output below Specifications; Output below Specifications

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE AIR RECIPROCATOR DEVICE MOTOR POWER WAS TOO LOW AND TOO WEAK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR FREQUENCY, AIR LEAK AND SAW HEAD. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A DAMAGED HOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673337 ↗