MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problems Abrasion (1689); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Zoll has not received the product for investigation.The customer did not provide the details of the patient, date of problem occurrence and the serial number of the autopulse platform involved.Per customer, the head restraint got broken over usage and it's been that way for a long time without regular preventive maintenance.A follow-up report will be submitted when the product is returned and investigation has been completed.Per autopulse system user guide "inspect the autopulse platform daily for physical damage, including cracks, tears and missing or broken pieces.Contact zoll as needed." chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." based on available information, the event of patient's minor superficial capillary bleeding in skin was not serious since it didn't meet any criteria of seriousness per regulations.Due to the head restraint got broken over usage and it's been that way for a long time without regular preventive maintenance, the event of minor superficial capillary bleeding in skin was caused by user error, and it was not related to the autopulse device.The user may be re-trained by user guide.

Event Description

During patient use, the user noticed broken head restraint on the top cover of the autopulse platform which eventually poked patient's skin and caused minor superficial capillary bleeding.Per customer there was no any other serious injury or adverse impact to the patient.The customer did not provide the details of the patient, date of problem occurrence and the serial number of the autopulse platform involved.Per customer, the head restraint got broken over usage and it's been that way for a long time without regular preventive maintenance.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10350601
• MDR Text Key: 201378119
• Report Number: 3010617000-2020-00725
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other